Difference between revisions of "Staging page"

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[[#top|Back to Top]]
 
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{{#lst:Section editor transclusions|giei}}
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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<big>Note: there is some overlap, especially in the earlier literature, between treatment regimens for cholangiocarcinoma and those for '''[[pancreatic cancer|pancreatic adenocarcinoma]]''', '''[[periampullary adenocarcinoma]]''', and '''[[gallbladder cancer]]'''; please see those pages for additional regimens.</big><br>
 
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''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Cholangiocarcinoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!''
 
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{{TOC limit|limit=3}}
 
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=Guidelines=
 
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==[https://asco.org/ ASCO]==
 
−
*'''2019:''' Shroff et al. [https://doi.org/10.1200/JCO.18.02178 Adjuvant therapy for resected biliary tract cancer: ASCO Clinical Practice Guideline]
 
−
==[http://www.esmo.org/ ESMO]==
 
−
*'''2016:''' Valle et al. [https://www.esmo.org/Guidelines/Gastrointestinal-Cancers/Biliary-Cancer Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up]
 
−
==[https://www.nccn.org/ NCCN]==
 
−
*[https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf NCCN Guidelines - Hepatobiliary Cancers]
 
−
=Adjuvant therapy=
 
−
==Capecitabine monotherapy {{#subobject:f4c3d9|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:3a3bdf|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(18)30915-X Primrose et al. 2019 (BILCAP)]
 
−
|2006-2014
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Observation|Observation]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<sup>1</sup><br>Median OS: 49.6 vs 36.1 mo<br>(aHR 0.84, 95% CI 0.67-1.06)
 
−
|}
 
−
''<sup>1</sup>Reported efficacy is based on the 2022 update.''<br>
 
−
''Note: Chemotherapy start date 8 to 16 weeks after surgery''
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery|Surgical resection]] with macroscopically curative resection
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
'''21-day cycle for 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://doi.org/10.1016/S1470-2045(18)30915-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/30922733 PubMed] NCT00363584
 
−
##'''Update:''' Bridgewater J, Fletcher P, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans TR, Stocken D, Stubbs C, Praseedom R, Ma YT, Davidson B, Neoptolemos J, Iveson T, Cunningham D, Garden OJ, Valle JW, Primrose J; BILCAP study group. Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study. J Clin Oncol. 2022 Jun 20;40(18):2048-2057. Epub 2022 Mar 22. [https://doi.org/10.1200/jco.21.02568 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35316080/ PubMed]
 
−
==Capecitabine & Gemcitabine {{#subobject:17f9f2|Regimen=1}}==
 
−
GemCap: '''<u>Gem</u>'''citabine & '''<u>Cap</u>'''ecitabine
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:e6a3e3|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4534524/ Ben-Josef et al. 2015 (SWOG S0809)]
 
−
|2008-2012
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery#Surgical_resection|Surgical resection]]
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 750 mg/m<sup>2</sup>/day PO twice per day on days 1 to 14
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
'''21-day cycle for 4 cycles'''
 
−
</div>
 
−
<div class="toccolours" style="background-color:#cbd5e7">
 
−
====Subsequent treatment====
 
−
*[[#Capecitabine_.26_RT_88|Capecitabine & RT]]
 
−
</div></div>
 
−
===References===
 
−
#'''SWOG S0809:''' Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. Epub 2015 May 11. [https://doi.org/10.1200/JCO.2014.60.2219 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4534524/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25964250 PubMed] NCT00789958
 
−
==Gemcitabine monotherapy {{#subobject:f8c8d9|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:4c4adf|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/full/10.1002/bjs.10776 Ebata et al. 2018 (BCAT)]
 
−
|2007-2011
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Observation|Observation]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
−
|}
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery|Surgical resection]] with macroscopically curative resection
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
'''28-day cycle for 6 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://doi.org/full/10.1002/bjs.10776 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29405274 PubMed] UMIN000000820
 
−
==Gemcitabine/Fluorouracil & RT {{#subobject:f8c8d9|Regimen=1}}==
 
−
Gemcitabine/Fluorouracil & RT: Gemcitabine alternating with Fluorouracil & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Protocol {{#subobject:3fef3f|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[http://jama.ama-assn.org/content/299/9/1019.long Regine et al. 2008 (RTOG 9704)]
 
−
|1998-2002
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[#Fluorouracil_.26_RT|Fluorouracil & RT]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>Reported efficacy is based on the 2011 update.''<br>
 
−
''Note: this study was in pancreatic cancer but in practice it is extrapolated to cholangiocarcinoma.''
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery#Surgical_resection|Surgical resection]]
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy, part 1====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 
−
'''21-day course, followed in 1 to 2 weeks by:'''
 
−
====Chemotherapy, part 2====
 
−
*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion throughout radiation therapy
 
−
====Radiotherapy====
 
−
*Concurrent [[External_beam_radiotherapy|radiation therapy]], 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
 
−
'''6-week course, followed in 3 to 5 weeks by:'''
 
−
====Chemotherapy, part 3====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 
−
'''28-day cycle for 3 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''RTOG 9704:''' Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18319412 PubMed] NCT00003216
 
−
##'''Update:''' Regine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the US Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. Epub 2011 Mar 10. [https://link.springer.com/article/10.1245/s10434-011-1630-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3548408/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21499862 PubMed]
 
−
==GemOx {{#subobject:f8c8d9|Regimen=1}}==
 
−
GemOx: '''<u>Gem</u>'''citabine & '''<u>Ox</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:3ghg3f|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.18.00050 Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI)]
 
−
|2009-2014
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Observation|Observation]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS
 
−
|}
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery|Surgical resection]] with macroscopically curative resection
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV once on day 2
 
−
'''14-day cycle for 12 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00050 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30707660 PubMed] NCT01313377
 
−
=Metastatic, first-line therapy=
 
−
==CapeOx {{#subobject:cf9acc|Regimen=1}}==
 
−
CapeOx: '''<u>Cape</u>'''citabine & '''<u>Ox</u>'''aliplatin
 
−
<br>XELOX: '''<u>XEL</u>'''oda (Capecitabine) & '''<u>OX</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:1ef938|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdz058 Kim et al. 2019 (SMC 2011-05-070)]
 
−
|2011-2016
 
−
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
−
|[[#GemOx_2|GEMOX]]
 
−
| style="background-color:#eeee01" |Non-inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV once on day 1
 
−
'''21-day cycle for 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://doi.org/10.1093/annonc/mdz058 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30785198 PubMed] NCT01470443
 
−
==Cisplatin & Gemcitabine (GC) {{#subobject:8ug357|Regimen=1}}==
 
−
GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:cb3ttq|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|Awaiting publication (TOPAZ-1)
 
−
|2019-2021
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Cisplatin_.26Gemcitabine_.28GC.29_.26_Durvalumab|GC & Durvalumab]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS
 
−
|-
 
−
|}
 
−
''Note: dosing information is from the FDA approval announcement.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
'''21-day cycle for up to 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''TOPAZ-1:''' NCT03875235
 
−
==Cisplatin & Gemcitabine (GC) & Durvalumab {{#subobject:dub057|Regimen=1}}==
 
−
GC & Durvalumab: '''<u>G</u>'''emcitabine, '''<u>C</u>'''isplatin, Durvalumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:cb6g11|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|Awaiting publication (TOPAZ-1)
 
−
|2019-2021
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
−
|[[#Cisplatin_.26Gemcitabine_.28GC.29|GC]]
 
−
| style="background-color:#91cf60" |Seems to have superior OS<br>Median OS: 12.8 vs 11.5 mo<br>(HR 0.80, 95% CI 0.66-0.97)
 
−
|-
 
−
|}
 
−
''Note: efficacy and dosing information are from the FDA approval announcement.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] as follows:
 
−
**Cycles 1 up to 8: 25 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
*[[Gemcitabine (Gemzar)]] as follows:
 
−
**Cycles 1 up to 8: 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
====Immunotherapy====
 
−
*[[Durvalumab (Imfinzi)]] 1500 mg IV once on day 1
 
−
'''21-day cycle for up to 8 cycles, then 28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''TOPAZ-1:''' NCT03875235
 
−
==ECF {{#subobject:57bd6d|Regimen=1}}==
 
−
ECF: '''<u>E</u>'''pirubicin, '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:f87869|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ Rao et al. 2005]
 
−
|1997-2003
 
−
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
−
|[[#FELV|FELV]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Epirubicin (Ellence)]] 50 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 200 mg/m<sup>2</sup>/day IV continuous infusion over 21 days, started on day 1 (total dose per cycle: 4200 mg/m<sup>2</sup>)
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://doi.org/10.1038/sj.bjc.6602576 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/15856037 PubMed]
 
−
==FELV {{#subobject:ut11a8|Regimen=1}}==
 
−
FELV: '''<u>F</u>'''luorouracil , '''<u>E</u>'''toposide & '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid)
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:8e152d|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ Rao et al. 2005]
 
−
|1997-2003
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#ECF|ECF]]
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first'''
 
−
*[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second'''
 
−
*[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given third'''
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://doi.org/10.1038/sj.bjc.6602576 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/15856037 PubMed]
 
−
==Gemcitabine & nab-Paclitaxel {{#subobject:fbd698|Regimen=1}}==
 
−
NG: '''<u>N</u>'''ab-Paclitaxel & '''<u>G</u>'''emcitabine
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:ecc1c9|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6440720/ Sahai et al. 2018 (PrE0204)]
 
−
|2014-2016
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
''Note: this regimen was intended for ECOG PS 0 to 2, and Child-Pugh score less than 8.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 125 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''PrE0204:''' Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. nab-Paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma: a phase 2 clinical trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. [https://jamanetwork.com/journals/jamaoncology/article-abstract/2698042 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6440720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30178032 PubMed] NCT02181634
 
−
==GemOx {{#subobject:a99e6e|Regimen=1}}==
 
−
GemOx: '''<u>Gem</u>'''citabine & '''<u>Ox</u>'''aliplatin
 
−
<br>GEMOX: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:a6c33cb|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdz058 Kim et al. 2019 (SMC 2011-05-070)]
 
−
|2011-2016
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#CapeOx|XELOX]]
 
−
| style="background-color:#eeee01" |Non-inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 1
 
−
'''21-day cycle for 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://doi.org/10.1093/annonc/mdz058 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30785198 PubMed] NCT01470443
 
−
=Metastatic disease, all lines of therapy=
 
−
==Capecitabine monotherapy {{#subobject:c7cfeb|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:b34ea|Variant=1}}===
 
−
{| class="wikitable" style="width: 40%; text-align:center;"
 
−
! style="width: 50%" |Study
 
−
! style="width: 50%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1002/cncr.20368 Patt et al. 2004]
 
−
| style="background-color:#ffffbe" |Retrospective
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [https://doi.org/10.1002/cncr.20368 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15274071 PubMed]
 
−
==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:a46bbd|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdh096 Kornek et al. 2004]
 
−
|2000-2001
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ic)
 
−
|[[#Gemcitabine_.26_Mitomycin|Gemcitabine & Mitomycin]]
 
−
| style="background-color:#d9ef8b" |Might have superior ORR
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
*[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1
 
−
====Supportive therapy====
 
−
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [https://doi.org/10.1093/annonc/mdh096 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14998852 PubMed]
 
−
==Cisplatin & Gemcitabine (GC) {{#subobject:af0357|Regimen=1}}==
 
−
GC: '''<u>G</u>'''emcitabine & '''<u>C</u>'''isplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:cb3c9d|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)]
 
−
|2002-2008
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[#Gemcitabine_monotherapy_2|Gemcitabine]]
 
−
| style="background-color:#1a9850" |Superior OS<br>Median OS: 11.7 vs 8.1 mo<br>(HR 0.64, 95% CI 0.52-0.80)
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdz402 Morizane et al. 2019 (FUGA-BT)]
 
−
|2013-2016
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Gemcitabine_.26_S-1|Gemcitabine & S-1]]
 
−
| style="background-color:#eeee01" |Seems to have non-inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8, '''given first'''
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8, '''given second'''
 
−
====Supportive therapy====
 
−
*Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate
 
−
*After cisplatin, 500 mL normal saline given over 30 minutes
 
−
'''21-day cycle for 4 to 8 cycles depending on response'''
 
−
</div></div>
 
−
===References===
 
−
#'''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://doi.org/10.1056/NEJMoa0908721 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20375404 PubMed] NCT00262769
 
−
#'''FUGA-BT:''' Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J; JCOG. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. [https://doi.org/10.1093/annonc/mdz402 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31566666 PubMed] UMIN000010667
 
−
#'''FIGHT-302:''' NCT03656536
 
−
#'''FOENIX-CCA3:''' NCT04093362
 
−
#'''KEYNOTE-966:''' NCT04003636
 
−
#'''NuTide:121:''' NCT04163900
 
−
#'''PROOF 301:''' NCT03773302
 
−
#'''SWOG S1815:''' NCT03768414
 
−
==Cisplatin & Gemcitabine (GC) & nab-Paclitaxel {{#subobject:17f9f2|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:e6a3e3|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6567834/ Shroff et al. 2019 (MDACC 2014-0524)]
 
−
|2015-2017
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|}
 
−
''Prolonged median PFS and OS vs reported for historical controls treated with gemcitabine-cisplatin alone. This is the dose after a mid-protocol amendment for hematologic toxicity.''
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8
 
−
*[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''MDACC 2014-0524:''' Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: a phase 2 clinical trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. Epub 2019 Apr 18. [https://jamanetwork.com/journals/jamaoncology/article-abstract/2730639 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6567834/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30998813 PubMed] NCT02392637
 
−
==Erlotinib & Bevacizumab {{#subobject:CMR1|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:CMV1|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917213/ Lubner et al. 2010 (MC044G)]
 
−
|2006-2008
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Erlotinib (Tarceva)]] 150 mg PO once per day
 
−
*[[Bevacizumab (Avastin)]] 5 mg/kg IV once per day on days 1 & 15
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''MC044G:''' Lubner SJ, Mahoney MR, Kolesar JL, Loconte NK, Kim GP, Pitot HC, Philip PA, Picus J, Yong WP, Horvath L, Van Hazel G, Erlichman CE, Holen KD. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study. J Clin Oncol. 2010 Jul 20;28(21):3491-7. Epub 2010 Jun 7. [https://doi.org/10.1200/jco.2010.28.4075 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917213/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20530271 PubMed] NCT00356889
 
−
==FELV {{#subobject:3658a8|Regimen=1}}==
 
−
FELV: '''<u>F</u>'''luorouracil , '''<u>E</u>'''toposide & '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid)
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:beef1c|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/oxfordjournals.annonc.a010676 Glimelius et al. 1996]
 
−
|1991-1995
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Best_supportive_care|Best supportive care]]
 
−
| style="background-color:#1a9850" |Superior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first'''
 
−
*[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second'''
 
−
*[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given third'''
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [https://doi.org/10.1093/oxfordjournals.annonc.a010676 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8879373 PubMed] content property of [http://hemonc.org HemOnc.org]
 
−
==FULV {{#subobject:7bfb92|Regimen=1}}==
 
−
FULV: 5-'''<u>FU</u>''' & '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid)
 
−
<br>FUFA: 5-'''<u>FU</u>''' (Fluorouracil) & '''<u>F</u>'''olinic '''<u>A</u>'''cid
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:38dd78|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/oxfordjournals.annonc.a010676 Glimelius et al. 1996]
 
−
|1991-1995
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Best_supportive_care|Best supportive care]]
 
−
| style="background-color:#1a9850" |Superior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given first'''
 
−
*[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given second, 40 minutes after Fluorouracil (5-FU)'''
 
−
'''14-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [https://doi.org/10.1093/oxfordjournals.annonc.a010676 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8879373 PubMed]
 
−
==FULV & Gemcitabine {{#subobject:eb427f|Regimen=1}}==
 
−
FULV & Gemcitabine: 5-'''<u>FU</u>''', '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid), Gemcitabine
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:85fb7b|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1200/jco.2001.19.20.4089 Gebbia et al. 2001]
 
−
|NR
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 600 mg/m<sup>2</sup> IV continuous infusion over 22 hours (total dose per cycle: 1000 mg/m<sup>2</sup>)
 
−
*[[Folinic acid (Leucovorin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [https://doi.org/10.1200/jco.2001.19.20.4089 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11600613 PubMed]
 
−
==Gemcitabine monotherapy {{#subobject:1129f1|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1 {{#subobject:b0f450|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)]
 
−
|2002-2008
 
−
| style="background-color:#1a9851" |Phase 3 (E-de-esc)
 
−
|[[#Cisplatin_.26_Gemcitabine_.28GC.29_2|Cisplatin & Gemcitabine]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 
−
'''28-day cycle for 3 to 6 cycles depending on response'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2 {{#subobject:fcd6f1|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1200/jco.2001.19.20.4089 Gebbia et al. 2001]
 
−
|NR
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 
−
'''30-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [https://doi.org/10.1200/jco.2001.19.20.4089 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11600613 PubMed]
 
−
#'''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://doi.org/10.1056/NEJMoa0908721 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20375404 PubMed] NCT00262769
 
−
==Gemcitabine, Cisplatin, S-1 {{#subobject:e0d17a|Regimen=1}}==
 
−
GCS: '''<u>G</u>'''emcitabine, '''<u>C</u>'''isplatin, '''<u>S</u>'''-1
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:87f9c7|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 Sakai et al. 2018 (KHBO1401-MITSUBA)]
 
−
|2014-NR
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[#Cisplatin_.26_Gemcitabine_.28GC.29_2|Cisplatin & Gemcitabine]]
 
−
| style="background-color:#d9ef8b" |Seems to have superior OS
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Tegafur, gimeracil, oteracil (S-1)]] 80 mg/m<sup>2</sup> PO once per day on days 1 to 7
 
−
'''14-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''Abstract:''' Sakai D, Kanai M , Kobayashi S, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Ishioka C, Sho M,  Takeyama Y,  Fujimoto J, Toyoda M,  Shimizu J, Goto T,  Yoshimura K, Hatano E, Nagano H,  Ioka T. Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). Annals of Oncology 29 (Supplement 8): viii205–viii270, 2018 [https://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 link to abstract] NCT02182778
 
−
==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:42a188|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdh096 Kornek et al. 2004]
 
−
|2000-2001
 
−
| style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ic)
 
−
|[[#Capecitabine_.26_Mitomycin|Capecitabine & Mitomycin]]
 
−
| style="background-color:#fee08b" |Might have inferior ORR
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 2000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 15
 
−
*[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1
 
−
====Supportive therapy====
 
−
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [https://doi.org/10.1093/annonc/mdh096 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14998852 PubMed]
 
−
==Gemcitabine & S-1 {{#subobject:afbc17|Regimen=1}}==
 
−
GS: '''<u>G</u>'''emcitabine & '''<u>S</u>'''-1
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:cb3b9cd|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |Years of enrollment
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdz402 Morizane et al. 2019 (FUGA-BT)]
 
−
|2013-2016
 
−
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
−
|[[#Cisplatin_.26_Gemcitabine_.28GC.29_2|Gemcitabine & Cisplatin]]
 
−
| style="background-color:#eeee01" |Seems to have non-inferior OS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]]
 
−
*[[Tegafur, gimeracil, oteracil (S-1)]]
 
−
</div></div>
 
−
===References===
 
−
#'''FUGA-BT:''' Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J; JCOG. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. [https://doi.org/10.1093/annonc/mdz402 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31566666 PubMed] UMIN000010667
 
−
==GemOx {{#subobject:a99e6e|Regimen=1}}==
 
−
GemOx: '''<u>Gem</u>'''citabine & '''<u>Ox</u>'''aliplatin
 
−
<br>GEMOX: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 1000/85, bi-weekly {{#subobject:508f1b|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|Years of enrollment
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
−
|[https://academic.oup.com/jjco/article/41/2/217/875887 Halim et al. 2011]
 
−
|2005-2009
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|ORR: 27.5%
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once on day 1, '''given first'''
 
−
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second'''
 
−
'''14-day cycles'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 1000/100, bi-weekly {{#subobject:a8fecb|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045(11)70301-1 Lee et al. 2011 (SMC 2008-12-024)]
 
−
|2009-2010
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#GemOx_.26_Erlotinib_88|GEMOX & Erlotinib]]
 
−
| style="background-color:#fee08b" |Might have inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 2
 
−
'''14-day cycles'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #3, 1000/100 ("GEMOX-3") {{#subobject:a8fefg|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|Years of enrollment
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ Harder et al. 2006]
 
−
|2002-2005
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|ORR: 26% (95% CI 14–44)
 
−
|-
 
−
|}
 
−
GEMOX-3: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin, 3 visits per month
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, '''given first'''
 
−
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given second'''
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H. Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer. 2006 Oct 9;95(7):848-52. [https://doi.org/10.1038/sj.bjc.6603334 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16969352 PubMed]
 
−
#Halim A, Ebrahim MA, Saleh Y. A phase II study of outpatient biweekly gemcitabine-oxaliplatin in advanced biliary tract carcinomas. Jpn J Clin Oncol. 2011 Feb;41(2):217-24. [https://academic.oup.com/jjco/article/41/2/217/875887 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21062755 PubMed]
 
−
#'''SMC 2008-12-024:''' Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. Epub 2011 Dec 20. [https://doi.org/10.1016/S1470-2045(11)70301-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22192731 PubMed] NCT01149122
 
−
#'''KN035-BTC:''' NCT03478488
 
−
==GEMOX-B {{#subobject:119bb0|Regimen=1}}==
 
−
GEMOX-B: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin, '''<u>B</u>'''evacizumab
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:3748a1|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1016/S1470-2045%2809%2970333-X Zhu et al. 2009 (MGH 05-349)]
 
−
|2006-2007
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once per day on days 1 & 15, '''given second'''
 
−
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given third'''
 
−
====Targeted therapy====
 
−
*[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15, '''given first'''
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''MGH 05-349:''' Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. Epub 2009 Nov 20. [https://doi.org/10.1016/S1470-2045%2809%2970333-X link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19932054 PubMed] NCT00361231
 
−
==Nivolumab monotherapy {{#subobject:gh317a|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:8ghb87|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7193528/ Kim et al. 2020 (MCC-18684)]
 
−
|2016-2018
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Immunotherapy====
 
−
*[[Nivolumab (Opdivo)]] as follows:
 
−
**Cycles 1 to 8: 240 mg IV once on day 1
 
−
**Cycle 9 onwards: 480 mg IV once on day 1
 
−
'''14-day cycle for 8 cycles, then 28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''MCC-18684:''' Kim RD, Chung V, Alese OB, El-Rayes BF, Li D, Al-Toubah TE, Schell MJ, Zhou JM, Mahipal A, Kim BH, Kim DW. A Phase 2 Multi-institutional Study of Nivolumab for Patients With Advanced Refractory Biliary Tract Cancer. JAMA Oncol. 2020 Jun 1;6(6):888-894. [https://doi.org/10.1001/jamaoncol.2020.0930 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7193528/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32352498/ PubMed] NCT02829918
 
−
==Pembrolizumab monotherapy {{#subobject:e0d17a|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:87f9c7|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4481136/ Le et al. 2015 (KEYNOTE-016)]
 
−
|2013-2016
 
−
| style="background-color:#ffffbe" |Phase 2, <20 pts of this subtype
 
−
|-
 
−
|}
 
−
''Note: KEYNOTE-016 was an expansion to a CRC-specific trial.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Immunotherapy====
 
−
*[[Pembrolizumab (Keytruda)]] 10 mg/kg IV once on day 1
 
−
'''14-day cycle for up to 52 cycles (2 years)'''
 
−
</div></div>
 
−
===References===
 
−
# '''KEYNOTE-016:''' Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 2015 Jun 25;372(26):2509-20. Epub 2015 May 30. [https://doi.org/10.1056/NEJMoa1500596 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4481136/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26028255 PubMed] NCT01876511
 
−
## '''Update:''' Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. [http://science.sciencemag.org/content/357/6349/409.long link to original article]  [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/ link to PMC article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/28596308 PubMed]
 
−
==Pemigatinib monotherapy ==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen ===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8461541/ Abou-Alfa et al. 2020 (FIGHT-202)]
 
−
|2017-2019
 
−
| style="background-color:#91cf61" |Phase 2 (RT)
 
−
|-
 
−
|}
 
−
''Note: Patients with previously treated unresectable or metastatic disease.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Pemigatinib (Pemazyre)]] 13.5 mg PO once per day on days 1 to 14
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''FIGHT-202:''' Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Féliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. Epub 2020 Mar 20 [https://doi.org/10.1016/S1470-2045(20)30109-1 link to original article] '''contains dosing details in supplement''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8461541/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32203698 PubMed] NCT02924376
 
−
=Metastatic disease, subsequent lines of therapy=
 
−
==mFOLFOX6 {{#subobject:32d6c5|Regimen=1}}==
 
−
mFOLFOX6: '''<u>m</u>'''odified '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:205ad6|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ Lamarca et al. 2021 (ABC-06)]
 
−
|2014-2018
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Best_supportive_care|Active symptom control]]
 
−
| style="background-color:#91cf60" |Seems to have superior OS<br>Median OS: 6.2 vs 5.3 mo<br>(HR 0.69, 95% CI 0.50-0.97)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 2400 mg/m<sup>2</sup> IV continuous infusion over 46 hours (total dose per cycle: 2800 mg/m<sup>2</sup>)
 
−
*[[Folinic acid (Leucovorin)]] 350 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
'''14-day cycle for up to 12 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ABC-06:''' Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. Epub 2021 Mar 30. [https://doi.org/10.1016/s1470-2045(21)00027-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33798493/ PubMed] NCT01926236
 
−
==mFOLFOX6 (L-Leucovorin) {{#subobject:yg1tz5|Regimen=1}}==
 
−
mFOLFOX6: '''<u>m</u>'''odified '''<u>FOL</u>'''inic acid, '''<u>F</u>'''luorouracil, '''<u>OX</u>'''aliplatin
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:583ad6|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ Lamarca et al. 2021 (ABC-06)]
 
−
|2014-2018
 
−
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Best_supportive_care|Active symptom control]]
 
−
| style="background-color:#91cf60" |Seems to have superior OS<br>Median OS: 6.2 vs 5.3 mo<br>(HR 0.69, 95% CI 0.50-0.97)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 2400 mg/m<sup>2</sup> IV continuous infusion over 46 hours (total dose per cycle: 2800 mg/m<sup>2</sup>)
 
−
*[[Levoleucovorin (Fusilev)]] 175 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1
 
−
'''14-day cycle for up to 12 cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''ABC-06:''' Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. Epub 2021 Mar 30. [https://doi.org/10.1016/s1470-2045(21)00027-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8082275/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33798493/ PubMed] NCT01926236
 
−
==Futibatinib monotherapy {{#subobject:ahcx1g|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:2tty9d|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|Awaiting publication (TAS-120-101)
 
−
|2014-2021
 
−
| style="background-color:#91cf61" |Phase 1/2 (RT)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Futibatinib (Lytgobi)]] 20 mg PO once per day
 
−
'''Continued indefinitely'''
 
−
</div></div>
 
−
===References===
 
−
#'''TAS-120-101:''' NCT02052778
 
−
==Infigratinib monotherapy {{#subobject:afgh1g|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:yt719d|Variant=1}}===
 
−
{| class="wikitable sortable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075847/ Javle et al. 2017 (CBGJ398X2204)]
 
−
|2014-2020
 
−
| style="background-color:#91cf61" |Phase 2 (RT)
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*FGFR2 gene fusions or translocations or other FGFR genetic alterations
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Infigratinib (Truseltiq)]] 125 mg PO once per day on days 1 to 21
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''CBGJ398X2204:''' Javle M, Lowery M, Shroff RT, Weiss KH, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Van Cutsem E, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab T. Phase II study of BGJ398 in patients with FGFR-altered advanced cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282. Epub 2017 Nov 28. [https://doi.org/10.1200/JCO.2017.75.5009 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075847/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29182496 PubMed] NCT02150967
 
−
##'''Update:''' Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. Epub 2021 Aug 3. [https://doi.org/10.1016/s2468-1253(21)00196-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34358484/ PubMed]
 
−
==Ivosidenib monotherapy {{#subobject:af0357|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:cb3c9d|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7523268/ Abou-Alfa et al. 2020 (ClarIDHy)]
 
−
|2017-2019
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
−
|[[Cholangiocarcinoma_-_null_regimens#Placebo|Placebo]]
 
−
| style="background-color:#1a9850" |Superior PFS<br>Median PFS: 2.7 vs 1.4 mo<br>(HR 0.37, 95% CI 0.25-0.54)
 
−
|-
 
−
|}
 
−
''Note: Patients with unresectable or metastatic disease with IDH1 mutation with progression after at least one prior systemic therapy.''
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*IDH1 mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
<!-- #'''Abstract:''' GK Abou-Alfa, T Macarulla Mercade, M Javle, RK Kelley, S Lubner, J Adeva, JM Cleary, DV Catenacci, MJ Borad, JA Bridgewater, WP Harris, AG Murphy, D-Y Oh, J Whisenant, B Wu, L Jiang, C Gliser, SS Pandya, JW Valle, AX Zhu. ClarIDHy: A global, phase III, randomized, double-blind study of ivosidenib (IVO) vs placebo in pateints with advanced cholangiocarcinoma (CC) with an isocitrate dehydrogenase 1 (IDH1) mutation. Annals of Oncology, Volume 30, Issue Supplement-5, October 2019, mdz394.027. [https://doi.org/10.1093/annonc/mdz394.027 link to abstract] -->
 
−
#'''ClarIDHy:''' Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462. [https://doi.org/10.1016/s1470-2045(20)30157-1 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7523268/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32416072 PubMed] NCT02989857
 
−
##'''Update:''' Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Nov 1;7(11):1669-1677. [https://doi.org/10.1001/jamaoncol.2021.3836 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8461552/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34554208/ PubMed]
 
−
==Lenvatinib & Pembrolizumab {{#subobject:17f8ug|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:egh1e3|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|Awaiting publication (LEAP-005)
 
−
|2019-ongoing
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|}
 
−
''Note: Dosing details are from ASCO abstract #321 (2021).''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Lenvatinib (Lenvima)]] 20 mg PO once per day
 
−
====Immunotherapy====
 
−
*[[Pembrolizumab (Keytruda)]] as follows:
 
−
**Cycles 1 to 35: 200 mg IV once on day 1
 
−
'''35-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
*'''LEAP-005:''' NCT03797326
 
−
==Regorafenib monotherapy {{#subobject:17f9f2|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:e6a3e3|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402964/ Sun et al. 2019 (UPMC 13-100)]
 
−
|2014-2017
 
−
| style="background-color:#91cf61" |Phase 2
 
−
|}
 
−
''Only studied in patients with advanced biliary cancer who failed at least 1 line of systemic therapy.''
 
−
====Targeted therapy====
 
−
*[[Regorafenib (Stivarga)]] 120 mg PO once per day on days 1 to 21
 
−
'''28-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''UPMC 13-100:''' Sun W, Patel A, Normolle A, Patel K, Ohr J, Lee JJ, Bahary N, Chu E, Streeter N, Drummond S. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy-refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer. 2019 Mar 15;125(6):902-909. Epub 2018 Dec 18. [https://doi.org/10.1002/cncr.31872 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402964/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30561756 PubMed] NCT02053376
 
−
[[Category:Cholangiocarcinoma regimens]]
 
−
[[Category:Disease-specific pages]]
 
−
[[Category:Hepatobiliary cancers]]
 

Latest revision as of 00:13, 18 June 2023

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