Actively Recruiting
A Single-Arm Study of Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
Led by Tongji Hospital · Updated on 2026-03-23
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new combination treatment for patients with advanced biliary tract cancer. This study focuses on combining standard chemotherapy drugs gemcitabine and cisplatin with two additional medications, adebrelimab and simvastatin. The main goal is to gather initial data on whether this four-drug combination is a promising approach for treating this advanced cancer type. All participants will receive the same treatment regimen, starting with up to 8 cycles of the combination therapy given every 21 days. This includes intravenous adebrelimab at 1200 mg on day 1 of each cycle, the standard chemotherapy drugs gemcitabine and cisplatin given intravenously, and daily oral simvastatin at 20 mg. After these initial cycles, patients will continue maintenance therapy with adebrelimab every 4 weeks and daily simvastatin until the cancer progresses or side effects become unacceptable. During the study, patients will be closely monitored through regular assessments to track tumor shrinkage, how long the treatment controls cancer growth, and any side effects experienced. The primary measure of success is the objective response rate, assessed up to about 2 years. Secondary measures include progression-free survival, overall survival, disease control rate, duration of response, and treatment-related adverse events. Safety and treatment effects will be followed for up to 3 years from enrollment.
CONDITIONS
Brief Title
Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma
- No prior systemic therapy for advanced disease unless recurrence occurred more than 6 months after surgery or adjuvant therapy
- ECOG Performance Status of 0 or 1
- At least one measurable tumor lesion by RECIST 1.1 criteria
- No severe dysfunction of major organs such as heart, lungs, or brain
You will not qualify if you...
- Diagnosis of ampullary carcinoma
- Active or previously documented autoimmune or inflammatory disorders
- Known allergy to adebrelimab, gemcitabine, cisplatin, or simvastatin
- Severe liver dysfunction with elevated bilirubin or liver enzymes above specified limits
- Participation in another clinical trial of investigational drugs or devices within 4 weeks prior
- Inability to comply with study treatment or follow-up requirements
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 cycles of 21 days each followed by maintenance until disease progression or unacceptable toxicity
Participants receive a combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day cycles), followed by maintenance treatment with adebrelimab and simvastatin until disease progression or unacceptable toxicity.
1 visit per 21-day cycle during initial 8 cycles, then visits every 4 weeks during maintenance
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yang WU, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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