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RECRUITING
NCT07832006
PHASE2

Irreversible Electroporation Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

Sponsor: Shunda Du

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Irreversible Electroporation

Percutaneous or intraoperative irreversible electroporation performed according to institutional standards.

DRUG

Lenvatinib

Oral administration according to body weight and prescribing information.

DRUG

Sintilimab

200 mg intravenously every 3 weeks.

Locations (1)

Peking Union Medical College Hospital

Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, China