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A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

StatusRecruiting
PhasePhase 3
Started2026-01-21
View on ClinicalTrials.gov ↗

Amendment history

2026-01-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-11→confirmed 2026-01-21
Study sitesdetails revised at 1 of 1 site
2025-11-13
minor
Original filing
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
Trial Details
NCT Number NCT07229625
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Advanced Biliary Tract Cancer
Enrollment 604 participants
Start Date 2026-01-21
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-28