Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer: A Randomized, Open-label, Multicenter, Phase II Study
This study aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Cisplatin Plus Gemcitabine(CisGem), compared with Adebrelimab in Combination With CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer.
• Age 18\
⁃ 75 years old, both male and female;
• Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
• Has not received prior systemic anti-tumor therapy;
• At least one measurable lesion based on RECIST v1.1 criteria;
• ECOG PS score: 0-1 points;
• Expected survival period ≥ 3 months;
• Adequate organ function;
• Must take one medically approved contraceptive measure;
• Patients voluntarily joined the study and signed informed consent.