RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Shunda Du • ClinicalTrials.gov ID: NCT07832006

Registry updated: 2026-09-21

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Description

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.

Interventions

Irreversible Electroporation (Procedure)
Percutaneous or intraoperative irreversible electroporation performed according to institutional standards.
Lenvatinib (Drug)
Oral administration according to body weight and prescribing information.
Sintilimab (Drug)
200 mg intravenously every 3 weeks.

Eligibility criteria

Inclusion Criteria: * Age 18 to 75 years. * Clinically or pathologically confirmed hepatocellular carcinoma (HCC). * Unresectable HCC corresponding to CNLC stage IIa, IIb, or IIIa, without extrahepatic metastasis. * At least one measurable lesion according to RECIST version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Child-Pugh class A or B liver function. * Adequate organ function, including an absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥75 × 10⁹/L; hemoglobin ≥80 g/L; serum creatinine ≤1.5 × the upper limit of normal (ULN) or creatinine clearance ≥50 mL/min; total bilirubin ≤3 × ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN. * Suitable for treatment with lenvatinib and sintilimab according to institutional standards. * Able to understand and sign written informed consent. Exclusion Criteria: * Presence of extrahepatic metastasis. * Previous treatment with irreversible electroporation. * Prior systemic therapy that precludes treatment with lenvatinib or sintilimab. * Diffuse infiltrative HCC not suitable for IRE evaluation. * Uncontrolled ascites, hepatic encephalopathy, or active gastrointestinal bleeding. * Active severe infection requiring systemic treatment. * Active tuberculosis. * Uncontrolled hepatitis B virus replication despite antiviral therapy. * Clinically significant cardiovascular disease, including uncontrolled hypertension, recent myocardial infarction, unstable angina, or severe arrhythmia. * Concurrent malignancy requiring active treatment. * Pregnancy or breastfeeding. * Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of the study results.

Conditions

Hepatocellular Carcinoma (HCC)

Locations

Peking Union Medical College Hospital — Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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