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

SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study

Cohort A and B: This cohort 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. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with Advanced Biliary Tract cancer.

Inclusion Criteria:

1. Age 18~75 years old, both male and female;
2. Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);
3. Has not received prior systemic anti-tumor therapy;
4. At least one measurable lesion based on RECIST v1.1 criteria;
5. ECOG PS score: 0-1 points;
6. Expected survival period ≥ 3 months;
7. Adequate organ function;
8. Must take one medically approved contraceptive measure;
9. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

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