{"entity":{"id":"abc-02","kind":"trial","name":"ABC-02","aka":[],"tldr":"ABC-02 was the 2010 UK trial that gave bile duct cancer its first standard chemotherapy: 410 patients with advanced biliary tract cancer were randomised to gemcitabine plus cisplatin or gemcitabine alone, and the doublet lengthened life and delayed progression. It stayed the control arm for every first-line trial for more than a decade.","summary":"ABC-02, sponsored by Cancer Research UK and reported in the New England Journal of Medicine in 2010, was the UK trial that gave bile duct cancer its first standard chemotherapy, gemcitabine plus cisplatin. It randomised 410 patients with locally advanced or metastatic biliary tract cancer to the doublet or gemcitabine alone, met its primary overall survival endpoint and delayed progression, and remained the control arm for every subsequent first-line trial for more than a decade. OnCo links it to biliary tract and gallbladder cancer, the gemcitabine plus cisplatin record, Cancer Research UK and Juan W. Valle, and the result was confirmed by the Japanese BT22 trial. Whether triplet chemotherapy or immunotherapy additions, as in TOPAZ-1, now make the doublet alone obsolete is the question that followed.","status":"positive","asOf":"2026-09-07","links":[{"label":"NEJM 2010","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa0908721"},{"label":"ClinicalTrials.gov NCT00262769","url":"https://clinicaltrials.gov/study/NCT00262769"},{"label":"ISRCTN82956140","url":"https://www.isrctn.com/ISRCTN82956140"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["gemcitabine-cisplatin"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":[],"trials":[],"people":["juan-valle"],"bottlenecks":[],"keyPapers":["paper-abc-02-gemcitabine-cisplatin-nejm-2010"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: the registry conditions are extrahepatic bile duct cancer and gallbladder cancer, and eligibility was histologically or cytologically confirmed biliary tract, gallbladder or ampullary carcinoma; sponsored by University College London and run at 25 UK sites (ClinicalTrials.gov NCT00262769, ISRCTN82956140)."],"nct":"NCT00262769","phase":"3","setting":"Locally advanced or metastatic biliary tract cancer: gemcitabine + cisplatin vs gemcitabine","sponsor":"Cancer Research UK","result":"OS 11.7 vs 8.1 months, HR 0.64.","started":"2005-05","yearReported":2010,"enrolled":410,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Gemcitabine + cisplatin","n":204,"value":11.7},{"name":"Gemcitabine","n":206,"value":8.1}],"hr":0.64,"ci":[0.52,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0908721"}],"replication":"Confirmed by the Japanese BT22 trial and a decade of use as control arm."},"route":"/trials/abc-02/","neighbours":{"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"}],"institution":[{"id":"cruk","kind":"institution","name":"Cancer Research UK","route":"/institutions/cruk/"}],"person":[{"id":"john-bridgewater","kind":"person","name":"John Bridgewater","route":"/people/john-bridgewater/"},{"id":"juan-valle","kind":"person","name":"Juan W. Valle","route":"/people/juan-valle/"}],"paper":[{"id":"paper-abc-02-gemcitabine-cisplatin-nejm-2010","kind":"paper","name":"ABC-02: cisplatin plus gemcitabine versus gemcitabine alone for biliary tract cancer","route":"/key-papers/paper-abc-02-gemcitabine-cisplatin-nejm-2010/"}],"term":[{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}]}}