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

NCT07392541 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Wanguang Zhang, M.D. · Tongji Hospital

  • Zeyang Ding, M.D. · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2028-01-30
Completion
2028-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392541 on ClinicalTrials.gov