# BILCAP

Source: https://onco.cc/trials/bilcap/  
OnCo record `bilcap` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Six months of oral chemotherapy after surgery became the standard for bile duct cancer despite a technically negative primary result.

## Summary

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.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-07
- Tags: lesson:itt-vs-per-protocol
- Registry id: ISRCTN72785446
- Phase: 3
- Setting: Adjuvant capecitabine for 6 months vs observation after resection of biliary tract cancer
- Sponsor: Cancer Research UK
- Enrolled: 447
- Result: OS 51.1 vs 36.4 months; ITT HR 0.81 (p=0.097), per-protocol HR 0.75.
- Outcomes: Overall survival (ITT): Capecitabine 51.1 months vs Observation 36.4 months, HR 0.81; Overall survival (per protocol): Capecitabine 53 months vs Observation 36 months, HR 0.75; Overall survival (ITT, sensitivity analysis adjusted for minimisation factors, nodal status, grade and sex): Capecitabine 51.1 months vs Observation 36.4 months, HR 0.71; Recurrence-free survival (ITT): Capecitabine 24.4 months vs Observation 17.5 months; Overall survival (ITT, long-term analysis, median follow-up 106 months): Capecitabine 49.6 months vs Observation 36.1 months, HR 0.84; Grade 3 toxicity, capecitabine arm (at least one event): Capecitabine (213 treated) 44%

## Notes

- Gallbladder cancer: BILCAP enrolled histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after macroscopically complete resection at 44 UK hepatopancreatobiliary centres, so its result is the adjuvant evidence for gallbladder cancer from T1b upward. Registered as ISRCTN72785446, NCT00363584 and EudraCT 2005-003318-13; funded by Cancer Research UK and Roche. The long-term analysis (2022, median follow-up 106 months) kept the intention-to-treat hazard ratio at 0.84 (0.67 to 1.06) and the adjusted sensitivity analysis at 0.74 (0.59 to 0.94).

## Sources

- ISRCTN registry entry (ISRCTN72785446): https://www.isrctn.com/ISRCTN72785446
- Primrose et al., Lancet Oncology 2019: https://doi.org/10.1016/S1470-2045(18)30915-X
- ISRCTN72785446: https://www.isrctn.com/ISRCTN72785446
- ClinicalTrials.gov NCT00363584: https://clinicaltrials.gov/study/NCT00363584
- Bridgewater et al., JCO 2022: long-term outcomes of BILCAP: https://doi.org/10.1200/JCO.21.02568

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder adenocarcinoma](https://onco.cc/cancers/gallbladder-adenocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Incidental gallbladder cancer (found after cholecystectomy)](https://onco.cc/cancers/incidental-gallbladder-cancer/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- institutions: [Addenbrooke's Hospital, Cambridge University Hospitals](https://onco.cc/institutions/addenbrookes-cambridge/), [Cancer Research UK](https://onco.cc/institutions/cruk/), [Derriford Hospital, University Hospitals Plymouth](https://onco.cc/institutions/derriford-plymouth/)
- people: [John Bridgewater](https://onco.cc/people/john-bridgewater/), [John N. Primrose](https://onco.cc/people/john-primrose/)
- key papers: [BILCAP: capecitabine compared with observation in resected biliary tract cancer](https://onco.cc/key-papers/paper-bilcap-lancet-oncol-2019/), [Biliary Tract Cancers, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology](https://onco.cc/key-papers/paper-nccn-biliary-tract-cancers-v2-2025-jnccn-2025/), [Management of incidental gallbladder cancer in the nationwide CAPBIL study](https://onco.cc/key-papers/paper-mcclements-capbil-incidental-gallbladder-cancer-bjs-2026/), [Surgical outcomes in gallbladder cancer: evidence from the UK nationwide CAPBIL study](https://onco.cc/key-papers/paper-mcclements-capbil-surgical-outcomes-gallbladder-cancer-hpb-2026/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)
- trials: [ACTICCA-1](https://onco.cc/trials/acticca-1/), [SWOG S0809](https://onco.cc/trials/swog-s0809/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)
- ideas: [A ctDNA residual disease-guided adjuvant trial after gallbladder cancer resection](https://onco.cc/ideas/idea-gbc-ctdna-residual-disease-guided-adjuvant-trial/), [A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection](https://onco.cc/ideas/idea-gbc-randomised-adjuvant-chemoradiation-r1-node-positive/), [Report gallbladder cancer as its own population in every biliary trial](https://onco.cc/ideas/idea-gbc-report-gallbladder-separately-in-biliary-trials/)

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