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)
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.
• Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
• No previous systemic anti-tumor treatment has been received;
• At least one measurable lesion that complies with the RECIST v1.1 standard;
• ECOG PS score: 0-1 point;
• The expected survival period is ≥ 3 months;
• Good organ function level;
• Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
• Patients voluntarily joined this study and signed informed consent.