Actively Recruiting
Phase 2 Study of Combined Gemcitabine and Cisplatin Chemotherapy with Lenvatinib and Adebrelimab for Advanced Unresectable Intrahepatic Cholangiocarcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-07-03
38
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with advanced and unresectable intrahepatic cholangiocarcinoma ICC, a type of liver cancer with poor survival rates and limited treatment options. This phase 2 study aims to assess the safety and effectiveness of combining gemcitabine and cisplatin chemotherapy with Lenvatinib, a targeted therapy, and Adebrelimab, an immune checkpoint inhibitor. Participants will receive gemcitabine and cisplatin chemotherapy every 3 weeks for a total of 6 cycles. Lenvatinib is taken orally once daily at 8 mg, and Adebrelimab is given intravenously every 3 weeks at 1200 mg. Both Lenvatinib and Adebrelimab treatments continue for up to 2 years. This combined therapy is being studied as a single treatment arm in this trial. During the study, participants will be monitored for tumor response and disease progression using objective response rates and other measures such as disease control rate and survival times, assessed for up to approximately 3 years. Safety will be closely followed by tracking treatment-related adverse events. The study involves regular clinical evaluations, laboratory tests, and imaging to assess treatment effects and participant health over time.
CONDITIONS
Brief Title
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
Research Team
M
Mengya Zang
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