{"entity":{"id":"nct07745296","kind":"trial","name":"Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer","aka":["SAFIR-IMPACT"],"tldr":"A phase 3 trial of zanidatamab, capecitabine, futibatinib and ivosidenib in gallbladder cancer and other biliary tract cancers, run by UNICANCER, not yet recruiting.","summary":"Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer is a phase 3, randomised interventional study registered as NCT07745296 by UNICANCER, with a registry enrolment figure of 990 participants, started 2027-01-02 and due to reach its primary completion in 2033-07-02. Interventions recorded: Futibatinib, Ivosidenib + Capecitabine, Zanidatamab + Capecitabine, Capecitabine (Xeloda). Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: \"2. Histologically-proven intrahepatic cholangiocarcinoma, perihilar or distal extrahepatic cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma is excluded)\". No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07745296","url":"https://clinicaltrials.gov/study/NCT07745296"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer","ampullary"],"sections":[],"technologies":["bispecific-antibody","cytotoxic-chemotherapy","kinase-inhibitors","idh-inhibitors"],"targets":[],"drugs":["zanidatamab","capecitabine","futibatinib","ivosidenib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07745296","phase":"3","setting":"Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer","sponsor":"UNICANCER","enrolled":990,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07745296/","neighbours":{"cancer":[{"id":"ampullary","kind":"cancer","name":"Ampullary cancer (ampulla of Vater)","route":"/cancers/ampullary/"},{"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":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"idh-inhibitors","kind":"technology","name":"IDH inhibitors","route":"/technologies/idh-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"futibatinib","kind":"drug","name":"Futibatinib","route":"/drugs/futibatinib/"},{"id":"ivosidenib","kind":"drug","name":"Ivosidenib","route":"/drugs/ivosidenib/"},{"id":"zanidatamab","kind":"drug","name":"Zanidatamab","route":"/drugs/zanidatamab/"}],"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/"}]}}