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Clinical Trials in China / NCT07832006
Recruiting Phase 2

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

NCT07832006 · tracked via the Priya Life Science China tracker
Sponsor
Shunda Du
Phase
Phase 2
Started
2025-04-01
Last updated
2026-09-21

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Irreversible ElectroporationLenvatinib →Sintilimab →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective Response Rate (ORR) — From treatment initiation until conversion surgery, first documented disease progression, or treatment discontinuation, whichever occurs first, with tumor response assessed approximately every month, up to 24 months.
    The proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
  • Conversion Surgery Rate — From treatment initiation until curative-intent conversion surgery, disease progression, or treatment discontinuation, whichever occurs first, assessed up to 24 months.
    Proportion of patients who undergo curative-intent surgical resection after study treatment based on multidisciplinary evaluation.

Trial sites (1)

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

On this site

📄 Lenvima (lenvatinib) drug profile →

More Shunda Du trials in China

Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC Recruiting

Other trials for the same condition

HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03) Recruiting
FAD Subtype-Guided Combination Therapy for Unresectable Hepatocellular Carcinoma Starting soon
GPC3-Targeted PET/CT in Hepatocellular Carcinoma Recruiting
Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca Active, not recruiting
FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07832006 on ClinicalTrials.gov ↗ ← All trials in China