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


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


  1. ECOG-ACRIN EA2197: NCT04559139

Adjuvant therapy



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


  1. 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


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.


  1. 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