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Six months of oral chemotherapy after surgery became the standard for bile duct cancer despite a technically negative primary result.
BILCAP, registered as ISRCTN72785446 and sponsored by Cancer Research UK, reported in 2017 and published in Lancet Oncology in 2019, made six months of oral capecitabine after surgery the standard for bile duct cancer despite a technically negative primary result. It randomised 447 patients to capecitabine or observation after resection, and the intention-to-treat overall survival analysis missed statistical significance while the per-protocol analysis was significant, after which ASCO and ESMO guidelines adopted it as standard adjuvant therapy. OnCo links it to biliary tract and gallbladder cancer, cytotoxic chemotherapy and Cancer Research UK. Whether a per-protocol result should set a standard of care, and whether adding immunotherapy or gemcitabine to adjuvant capecitabine improves on it, are the open questions.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
447 enrolled.
Hand-foot syndrome 20%, diarrhoea 8%, fatigue 8%
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (ITT)primary | Capecitabine | 223 | 51.1 months | 0.81 (0.63 to 1.04) | 0.097 | link |
| Observation | 224 | 36.4 months | ||||
| Overall survival (per protocol) | Capecitabine | 210 | 53 months | 0.75 (0.58 to 0.97) | 0.028 | link |
| Observation | 220 | 36 months | ||||
| Overall survival (ITT, sensitivity analysis adjusted for minimisation factors, nodal status, grade and sex) | Capecitabine | 223 | 51.1 months | 0.71 (0.55 to 0.92) | 0.010 | link |
| Observation | 224 | 36.4 months | ||||
| Recurrence-free survival (ITT) | Capecitabine | 223 | 24.4 months | - | - | link |
| Observation | 224 | 17.5 months | ||||
| Overall survival (ITT, long-term analysis, median follow-up 106 months) | Capecitabine | 223 | 49.6 months | 0.84 (0.67 to 1.06) | - | link |
| Observation | 224 | 36.1 months | ||||
| Grade 3 toxicity, capecitabine arm (at least one event) | Capecitabine (213 treated) | 213 | 44% | - | - | link |
This is the UK baseline for the incidental cancer pathway: a re-resection rate well above the Dutch registry's 24 percent, with the same selection caveat. The abstract leaves out the histology, referral and timing detail; the full paper holds it.
The adjuvant finding sits uneasily beside BILCAP, on which NHS adjuvant capecitabine rests; in a mostly gallbladder population the benefit is not visible. ACTICCA-1 and ARTEMIDE-Biliary01 are the trials that can settle it.
NCCN is the source of the category grades quoted on the gallbladder cancer page; the adjuvant section leans on BILCAP for capecitabine and on SWOG S0809 for chemoradiation after margin-positive or node-positive resection.
Adjuvant capecitabine is the standard after resection of intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer, endorsed by ASCO and ESMO guidelines.
Shares John Bridgewater, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares John Bridgewater, Report gallbladder cancer as its own population in every biliary trial, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares John N. Primrose, Management of incidental gallbladder cancer in the nationwide CAPBIL study, Surgical outcomes in gallbladder cancer: evidence from the UK nationwide CAPBIL study, Biliary tract cancer (all types).
Shares Report gallbladder cancer as its own population in every biliary trial, Gallbladder adenocarcinoma, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares SWOG S0809, A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Incidental gallbladder cancer (found after cholecystectomy), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).