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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: Cisplatin; Drug: SHR-8068; Drug: Adebrelimab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06465563

SHR-8068-201-BTC

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Adebrelimab

Drug: SHR-8068

Drug: Cisplatin

Arm B: Adebrelimab, Cisplatin and Gemcitabine

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Adebrelimab

Drug: Cisplatin