{"groups":[{"description":"Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"FG000","title":"Durvalumab + Gemcitabine + Cisplatin"},{"description":"Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"FG001","title":"Placebo + Gemcitabine + Cisplatin"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"}],"type":"Ongoing study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"8"}],"type":"Off treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"308"},{"groupId":"FG001","numSubjects":"326"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Re-consent refusal"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"341"},{"groupId":"FG001","numSubjects":"344"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"338"},{"groupId":"FG001","numSubjects":"342"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"341"},{"groupId":"FG001","numSubjects":"344"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Eligible patients previously untreated for unresectable locally advanced or metastatic Biliary Tract Cancer (BTC) were randomized in a 1:1 ratio with either Durvalumab in combination with Gemcitabine/Cisplatin or Placebo in combination with Gemcitabine/Cisplatin. Randomization was stratified by disease status (initially unresectable versus recurrent) and primary tumor site (IHCC versus EHCC versus GBC).","recruitmentDetails":"The study is active, not recruiting and conducted in 17 countries with 685 patients who were randomized prior to or on 18 December 2020. Results are reported for the study at data cut-off (DCO) 28 February 2025."}