Combination treatment for 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

This study is testing a new combination of treatments for advanced biliary tract cancer to see if it works better than the standard treatment for patients who haven't had therapy before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Adalimumab, Adebrelimab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06465563 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of combining SHR-8068 and Adebrelimab with Cisplatin and Gemcitabine as a first-line treatment for patients with advanced biliary tract cancer. It compares this combination to Adebrelimab with CisGem alone. The trial aims to determine which treatment regimen provides better outcomes for patients who have not previously received systemic therapy. Participants will be monitored for measurable lesions and overall health status throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable or metastatic biliary tract adenocarcinoma who have not received prior systemic therapy.

Not a fit: Patients with other solid tumors, significant liver tumor burden, or recent major surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced biliary tract cancer.

How similar studies have performed: Other studies have shown promise in using combination therapies for biliary tract cancer, but this specific combination is being evaluated for the first time.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xin Shi

Conditions Biliary Tract Cancer