NCT07392541

Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer

A Single-Arm, Multicenter, Exploratory Clinical Study of Adebrelimab in Combination With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Patients With Locally Advanced or Metastatic Biliary Tract Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin. All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.

Conditions

• Advanced Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab is an anti-PD-L1 monoclonal antibody. During the initial combination phase (up to 8 cycles), it is administered intravenously at 1200 mg on Day 1 of each 21-day cycle. During the subsequent maintenance phase, it is administered at 1200 mg intravenously every 4 weeks.
DRUG	Gemcitabine + Cisplatin	Standard gemcitabine and cisplatin chemotherapy regimen. This combination is administered intravenously only during the initial treatment phase for a maximum of 8 cycles (21-day cycles).
DRUG	Simvastatin 20mg	Simvastatin is an HMG-CoA reductase inhibitor (statin). It is administered orally at a dose of 20 mg once daily continuously throughout both the initial combination phase and the subsequent maintenance phase until treatment completion criteria are met.

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-01-30
• Completion: 2028-01-30
• First posted: 2026-02-06
• Last updated: 2026-03-23

Locations

1 site across 1 country: China