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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)
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Summary
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.
Official title: A Phase III, Randomized, Controlled, Open-Label, Multicenter 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
604
Start Date
2026-01-21
Completion Date
2029-12
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Cisplatin Injection
Cisplatin injection.
Durvalumab Injection
Durvalumab injection.
Locations (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China