# BILCAP: capecitabine compared with observation in resected biliary tract cancer

Source: https://onco.cc/key-papers/paper-bilcap-lancet-oncol-2019/  
OnCo record `paper-bilcap-lancet-oncol-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Six months of capecitabine tablets after surgery for bile duct or gallbladder cancer lengthened survival by about a year in the per-protocol analysis, and became the standard adjuvant treatment despite narrowly missing its primary endpoint.

## Summary

Phase 3 trial of 447 patients with completely resected cholangiocarcinoma (intrahepatic, perihilar or distal) or gallbladder cancer randomised to eight cycles of capecitabine or observation.

In the intention-to-treat analysis median overall survival was 51.1 versus 36.4 months (hazard ratio 0.81, not significant); in the prespecified per-protocol analysis it was 53 versus 36 months (hazard ratio 0.75, significant), and the adjusted analysis and long-term follow-up supported benefit.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: The Lancet Oncology
- Year: 2019
- DOI: 10.1016/S1470-2045(18)30915-X
- Authors: Primrose JN, Fox RP, Palmer DH, et al.
- Findings: Intention to treat: median overall survival 51.1 vs 36.4 months; hazard ratio 0.81 (not significant).; Per protocol: 53 vs 36 months; hazard ratio 0.75.
- What it means: Adjuvant capecitabine is the standard after resection of intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer, endorsed by ASCO and ESMO guidelines.
- Caveats: Primary endpoint not met in the intention-to-treat population.; Whether gemcitabine-cisplatin or chemo-immunotherapy adjuvant regimens are better is under study.

## Sources

- Lancet Oncol 2019: https://doi.org/10.1016/S1470-2045(18)30915-X
- PubMed: https://pubmed.ncbi.nlm.nih.gov/30922733/

## Connected records

- cancers: [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- trials: [BILCAP](https://onco.cc/trials/bilcap/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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