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ACTICCA-1 asks whether six months of gemcitabine and cisplatin after surgery beats the current standard for bile duct and gallbladder cancer. It recruited 789 patients across eight countries including 24 UK hospitals, has a separate gallbladder cohort, and finished recruiting; results are awaited.
ACTICCA-1 (NCT02170090) is an investigator-initiated, multinational randomised phase 3 trial led from Hamburg-Eppendorf and funded by Deutsche Krebshilfe, the Dutch Cancer Society and, for the UK sites, Cancer Research UK. Patients with histologically confirmed adenocarcinoma of the biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or muscle-invasive gallbladder carcinoma) after macroscopically complete resection were randomised within 16 weeks of surgery to gemcitabine and cisplatin for 24 weeks or to the standard of care, which was observation when the trial opened in 2014 and became capecitabine after BILCAP. The protocol enrolled cholangiocarcinoma and gallbladder carcinoma as two separate cohorts with their own sample sizes (271 and 154 evaluable patients) because of their different prognosis, stratified by nodal status; the primary endpoint is disease-free survival with overall survival, safety, quality of life and recurrence pattern as secondary endpoints. The registry records 789 patients enrolled at 67 sites in Australia, Austria, Denmark, Germany, Italy, the Netherlands, New Zealand and the United Kingdom, with primary completion in December 2025 and the trial active but no longer recruiting. No results were found in Europe PMC or on the registry in September 2026. For gallbladder cancer this is the only phase 3 with a dedicated cohort testing platinum doublet chemotherapy against capecitabine after surgery.
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).