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After surgery for bile duct or gallbladder cancer, a blood test for leftover tumour DNA picks out the people whose cancer will return with hazard ratios of 16 to 26 in two recent cohorts. Nobody has yet tested giving those people more than the standard capecitabine.
Tumour-informed ctDNA in the 2 to 12 week window after biliary resection was positive in 23 percent of 167 patients and carried a relapse-free survival hazard ratio of 15.86 (Malla 2026); in a 56-patient cohort the hazard ratio was 26 (Yu 2025). Gallbladder cancer recurs early and distantly after re-resection (Varshney 2025), which is the setting where a residual disease test could pick who gets escalation. The template exists in colon and bladder cancer (DYNAMIC, IMvigor011). A biliary trial would randomise ctDNA-positive patients after resection to capecitabine or gemcitabine-cisplatin with durvalumab, and could de-escalate ctDNA-negative T1b or T2a patients to observation.
Together with the JCO Precision Oncology cohort this makes residual disease testing in biliary cancer prognostic to the same degree as in colon cancer. Nobody has yet shown that acting on it helps; that is the trial gap the ideas on this page name.
Very wide confidence intervals from a small cohort, but the direction matches the larger 2026 analysis. Gallbladder cancer recurs early and distantly after re-resection, which is exactly the setting where a residual disease test could pick who gets more than capecitabine.
Shares ACTICCA-1, BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
Shares ACTICCA-1, BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types) and the tag gallbladder-evidence.
Shares Gemcitabine + cisplatin, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Neoadjuvant / adjuvant / perioperative, Durvalumab and the tag gallbladder-evidence.
Shares Gemcitabine + cisplatin, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Biliary tract cancer (all types), Durvalumab and the tag gallbladder-evidence.
Shares BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Neoadjuvant / adjuvant / perioperative, Capecitabine and the tag gallbladder-evidence.
Shares De-escalation, escalation and response-adapted therapy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Trial design, endpoints and cost, Gallbladder cancer and the tag gallbladder-evidence.
Shares De-escalation, escalation and response-adapted therapy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Trial design, endpoints and cost, Gallbladder cancer and the tag gallbladder-evidence.
Shares BILCAP, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.