{"entity":{"id":"abc-06","kind":"trial","name":"ABC-06","aka":[],"tldr":"ABC-06 was the first randomised trial to show that a second round of chemotherapy, FOLFOX, helps people with bile duct and gallbladder cancer live somewhat longer once gemcitabine and cisplatin have stopped working.","summary":"The UK ABC-06 trial randomised 162 patients with locally advanced or metastatic biliary tract cancer (cholangiocarcinoma, gallbladder or ampullary cancer) whose disease had progressed on first-line gemcitabine and cisplatin to active symptom control alone or with modified FOLFOX (oxaliplatin, folinic acid and fluorouracil). The primary endpoint was overall survival.\n\nFOLFOX produced a modest but significant improvement in overall survival with acceptable toxicity, and gave biliary cancer its first evidence-based second-line chemotherapy. Targeted drugs for FGFR2 and IDH1 alterations and the NIFTY trial of liposomal irinotecan have since added other options.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01926236","url":"https://clinicaltrials.gov/study/NCT01926236"},{"label":"Lamarca et al., Lancet Oncology 2021: ABC-06","url":"https://doi.org/10.1016/S1470-2045(21)00027-9"}],"tags":["subtype-trials"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin","folfox"],"companies":[],"institutions":[],"pathways":[],"terms":["gallbladder-cancer-in-biliary-trials"],"trials":[],"people":["juan-valle","angela-lamarca"],"bottlenecks":[],"keyPapers":["paper-abc-06-folfox-second-line-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: eligibility was histologically or cytologically verified non-resectable or recurrent or metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma after progression on cisplatin and gemcitabine (registry conditions: biliary tract cancer, gallbladder cancer, cholangiocarcinoma, ampullary cancer); the gallbladder share and a gallbladder-specific hazard ratio are not in the abstract. FOLFOX after gemcitabine and cisplatin is the NHS second-line standard that NICE used as the comparator for ivosidenib (TA948), pemigatinib (TA722) and zanidatamab (TA1153).","UK sites (17, registry): Queen Elizabeth Hospital Birmingham; Bristol Haematology and Oncology Centre; North Cumbria (Carlisle); Beatson (Glasgow); Castle Hill (Hull); St James's (Leeds); Clatterbridge (Liverpool); Guy's and St Thomas', Hammersmith, Royal Free and University College London (London); Maidstone Hospital; The Christie (Manchester); Nottingham City Hospital; Churchill (Oxford); Weston Park (Sheffield)."],"nct":"NCT01926236","phase":"3","setting":"Advanced biliary tract cancer after progression on gemcitabine and cisplatin: active symptom control with or without modified FOLFOX","sponsor":"The Christie NHS Foundation Trust","result":"Modified FOLFOX plus active symptom control modestly improved overall survival over active symptom control alone.","started":"2014-02","yearReported":2019,"enrolled":162,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":6.2,"note":"Adjusted hazard ratio; median follow-up 21.7 months"},{"name":"Active symptom control alone","n":81,"value":5.3}],"hr":0.69,"ci":[0.5,0.97],"p":"0.031","source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Overall survival at 12 months","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":25.9},{"name":"Active symptom control alone","n":81,"value":11.4}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Overall survival at 6 months","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":50.6},{"name":"Active symptom control alone","n":81,"value":35.5}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"},{"endpoint":"Grade 3-5 adverse events","unit":"%","arms":[{"name":"Active symptom control + FOLFOX","n":81,"value":69,"note":"Three chemotherapy-related deaths"},{"name":"Active symptom control alone","n":81,"value":52}],"source":"https://doi.org/10.1016/s1470-2045(21)00027-9"}]},"route":"/trials/abc-06/","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":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"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/"}],"person":[{"id":"angela-lamarca","kind":"person","name":"Angela Lamarca","route":"/people/angela-lamarca/"},{"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/"},{"id":"mairead-mcnamara","kind":"person","name":"Mairéad McNamara","route":"/people/mairead-mcnamara/"}],"paper":[{"id":"paper-abc-06-folfox-second-line-lancet-oncol-2021","kind":"paper","name":"Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial","route":"/key-papers/paper-abc-06-folfox-second-line-lancet-oncol-2021/"}],"trial":[{"id":"nifty","kind":"trial","name":"NIFTY","route":"/trials/nifty/"}],"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/"}],"idea":[{"id":"idea-gbc-report-gallbladder-separately-in-biliary-trials","kind":"idea","name":"Report gallbladder cancer as its own population in every biliary trial","route":"/ideas/idea-gbc-report-gallbladder-separately-in-biliary-trials/"}]}}