{"entity":{"id":"paper-bilcap-lancet-oncol-2019","kind":"paper","name":"BILCAP: capecitabine compared with observation in resected biliary tract cancer","aka":[],"tldr":"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.\n\nIn 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.","asOf":"2026-09-17","links":[{"label":"Lancet Oncol 2019","url":"https://doi.org/10.1016/S1470-2045(18)30915-X"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/30922733/"}],"tags":[],"related":[],"cancers":["extrahepatic-cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["bilcap"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2019,"doi":"10.1016/S1470-2045(18)30915-X","pmid":"30922733","authors":"Primrose JN, Fox RP, Palmer DH, et al.","paperType":"rct","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."],"whatItMeans":"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."],"changedPractice":true,"participants":447},"route":"/key-papers/paper-bilcap-lancet-oncol-2019/","neighbours":{"cancer":[{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"}],"trial":[{"id":"bilcap","kind":"trial","name":"BILCAP","route":"/trials/bilcap/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}