Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)
Almost every drug trial for gallbladder cancer also enrols bile duct cancers, so the evidence comes from mixed groups in which gallbladder cancer is usually a fifth to a half of patients. This entry lists the trials open to people with gallbladder cancer and what each reported for the gallbladder subgroup.
Overview
Gallbladder cancer is rarely trialled on its own. In the landmark trials it was one stratum among three: 25 percent of TOPAZ-1 patients had gallbladder cancer (FDA label), KEYNOTE-966 stratified randomisation by site of origin including gallbladder, ABC-06 enrolled gallbladder and ampullary cancer alongside cholangiocarcinoma, SWOG S1815 had 16 percent gallbladder cancer and BILCAP required muscle-invasive gallbladder cancer for entry. HER2 trials are the exception where gallbladder cancer dominates: 53 percent of HERIZON-BTC-01 patients had gallbladder cancer. Subgroup results are sparse and exploratory: in S1815 the triplet improved progression-free but not overall survival more in gallbladder cancer than in cholangiocarcinoma (interaction p 0.01 and 0.28), and in TreeTopp varlitinib gave a non-significant progression-free survival signal in gallbladder cancer (2.9 versus 1.6 months, hazard ratio 0.55, confidence interval crossing 1). Gallbladder-only randomised trials exist mainly in India (POLCAGB, RUGB, NEOGB) and the United States (OPT-IN) and address surgery, radiotherapy and neoadjuvant timing rather than new drugs. The trials linked here are every interventional phase 2 or 3 study on ClinicalTrials.gov or ISRCTN that was open or active in September 2026 and names gallbladder cancer in its conditions or eligibility, with UK sites quoted where the registry lists them.
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