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

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.

Eligibility

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.

Conditions2

Interventions3

Related trials

• A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC) — Tianjin Medical University Cancer Institute and Hospital
• A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer — Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
• A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC — Nanfang Hospital, Southern Medical University
• A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC — Zeng Jian
• A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer — Jin Ying
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma — The First Affiliated Hospital of Xiamen University
• A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer — Shanghai Hengrui Pharmaceutical Co., Ltd.

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