SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer

Inclusion criteria

• 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.

Exclusion criteria

• history or concurrently has other solid tumor;
• Patients with liver tumor burden greater than 50% of total liver volume;
• History of previous hepatic encephalopathy;
• Patients with biliary obstruction ， at risk of biliary tract infection;
• Patients with undergone major surgical treatment within 4 weeks before randomization;
• Patients with any active, known or suspected autoimmune disorder;
• Patients with active pulmonary tuberculosis;
• Patients with known history of HIV or active hepatitis;
• Untreated central nervous system metastasis;
• Pleural or peritoneal effusion with clinical symptoms;
• Patients with poorly controlled cardiac clinical symptoms or disease;
• Patients with abnormal coagulation function and bleeding tendency;
• Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug;
• Patients with other potential factors that may affect the study results.