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Irreversible Electroporation Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Sponsor: Shunda Du
Summary
Advanced hepatocellular carcinoma (HCC) remains a major therapeutic challenge. Although targeted therapy combined with immune checkpoint inhibitors has improved clinical outcomes, the objective response rate and conversion surgery rate remain suboptimal. Irreversible electroporation (IRE) is a non-thermal ablation technique that can induce tumor cell death while preserving surrounding vascular and biliary structures. Emerging evidence suggests that IRE may enhance anti-tumor immunity and synergize with systemic therapy. This prospective, single-center, open-label study aims to evaluate the efficacy and safety of IRE combined with lenvatinib and sintilimab in patients with advanced HCC. Eligible patients with unresectable CNLC stage IIa, IIb, or IIIa disease will receive standard targeted therapy and immunotherapy with or without IRE according to treatment allocation. The primary endpoints are objective response rate (ORR) and conversion surgery rate. Secondary endpoints include time to response (TTR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). The study is expected to provide evidence regarding the role of IRE in enhancing tumor response and increasing the likelihood of curative-intent surgical resection in patients with advanced HCC.
Official title: A Prospective Study of Irreversible Electroporation Combined With Lenvatinib and Sintilimab for Conversion Therapy in Patients With Advanced Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-04-01
Completion Date
2030-12-30
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Irreversible Electroporation
Percutaneous or intraoperative irreversible electroporation performed according to institutional standards.
Lenvatinib
Oral administration according to body weight and prescribing information.
Sintilimab
200 mg intravenously every 3 weeks.
Locations (1)
Peking Union Medical College Hospital
Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, China