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SAFIR-ABC10 profiles the tumour during first-line chemotherapy and then randomises people with a targetable change to a matched drug (for HER2, FGFR2, IDH1, BRAF or DNA repair defects) or to standard continuation. With 20 NHS hospitals taking part, it is the biggest precision-medicine trial open to UK patients with gallbladder cancer.
SAFIR-ABC10 (NCT05615818) is an international, randomised, controlled, open-label platform phase 3 led by UNICANCER at 69 sites in France, Belgium and the United Kingdom, open since July 2024 with 800 patients planned and primary completion listed for June 2027. Patients with histologically proven intrahepatic, perihilar or distal cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma excluded) undergo molecular profiling during induction gemcitabine and cisplatin; those with an actionable alteration are randomised to matched maintenance therapy or to standard of care. The registry lists futibatinib, ivosidenib, zanidatamab, trastuzumab, neratinib, encorafenib, binimetinib, niraparib, cisplatin and gemcitabine as interventions, covering FGFR2, IDH1, HER2, BRAF and homologous recombination alterations. The primary endpoint is progression-free survival. For gallbladder cancer, whose actionable alteration is most often HER2, the trial is the main randomised route to zanidatamab or trastuzumab-based maintenance in the UK outside HERIZON-BTC-302.
Shares Futibatinib, Ivosidenib, Zanidatamab, UNICANCER.
Shares University College London Hospitals / UCL Cancer Institute, UNICANCER, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares Zanidatamab, University College London Hospitals / UCL Cancer Institute, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares UNICANCER, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares University College London Hospitals / UCL Cancer Institute, Gemcitabine + cisplatin, The Royal Marsden, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Trastuzumab, Biliary tract cancer (all types).