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

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.

Inclusion Criteria:

• Age ≥ 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 ≥10 mm on CT scan, or lymph node with short axis ≥15 mm).
• No severe dysfunction of major organs (heart, lungs, brain, etc.).

Exclusion Criteria:

• 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.