Actively Recruiting
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 7 18 years.
- Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).
- No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months after radical surgery or adjuvant therapy is allowed.
- ECOG Performance Status of 0 or 1.
- At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter 710 mm on CT scan, or lymph node with short axis 715 mm).
- No severe dysfunction of major organs (heart, lungs, brain, etc.).
You will not qualify if you...
- Diagnosis of ampullary carcinoma.
- Presence of active or previously documented autoimmune or inflammatory disorders.
- Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin).
- Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin > 1.5 times the upper limit of normal (ULN), AND/OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times ULN.
- Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment.
- Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
- Any other condition deemed by the investigator as unsuitable for participation in the study.
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yang WU, M.D.
CONTACT
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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