NCT07832006RecruitingPhase 2
Irreversible Electroporation Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
A Prospective Study of Irreversible Electroporation Combined With Lenvatinib and Sintilimab for Conversion Therapy in Patients With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Shunda Du
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07832006
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Apr 2025 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with irreversible electroporation.
- Prior systemic therapy that precludes treatment with lenvatinib or sintilimab.
- Concurrent malignancy requiring active treatment.
Other illness
- 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.
- Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of the study results.
Other
- Presence of extrahepatic metastasis.
- Diffuse infiltrative HCC not suitable for IRE evaluation.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.