RecruitingPhase 2NCT06465563

Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer

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

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

80 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria14

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.