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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
604
SHR-8068 injection.
Adebrelimab injection.
Gemcitabine Hydrochloride for injection.
Cisplatin injection.
Durvalumab injection.
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGOverall Survival (OS)
Time frame: Up to 15 months.
Disease Control Rate (DCR)
Time frame: Up to 7 months.
Duration of Response (DoR)
Time frame: Up to 7 months.
Progression free Survival (PFS)
Time frame: Up to 7 months.
Objective Response Rate (ORR)
Time frame: Up to 7 months.
Time to Progression (TTP)
Time frame: Up to 7 months.
Time to Response (TTR)
Time frame: Up to 7 months.
Adverse events (AEs)
Time frame: Up to approximately 15 months.
Serious adverse events (SAEs)
Time frame: Up to approximately 15 months.
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