Gallbladder cancer - null regimens
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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main gallbladder cancer page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Awaiting publication (ECOG-ACRIN EA2197) | 2020-ongoing | Phase 3 (C) | GC | TBD if different primary endpoint of OS |
No systemic therapy prior to surgery.
Subsequent treatment
References
- ECOG-ACRIN EA2197: NCT04559139
Adjuvant therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Nakachi et al 2023 (ASCOT) | 2013-09-09 to 2018-06-22 | Phase 3 (C) | S-1 | Inferior OS |
No systemic therapy after surgery.
Preceding treatment
References
- ASCOT: Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J; Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023 Jan 21;401(10372):195-203. PMID: 36681415. link to original article PubMed UMIN000011688
Metastatic or unresectable disease, all lines of therapy
Best supportive care
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Sharma et al. 2010 | 2006-2008 | Randomized (C) | 1. FUFA | Did not meet primary endpoint of OS |
| 2. mGEMOX | Seems to have inferior OS |
No active antineoplastic treatment.
References
- Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article PubMed