Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label interventional study in patients with unresectable CNLC stage IIa–IIIa hepatocellular carcinoma. Participants receive standard targeted therapy with lenvatinib and the immune drug sintilimab, with or without the addition of irreversible electroporation (IRE). The primary goals are to measure objective tumor response and the rate of conversion to surgical resection, while secondary goals include survival outcomes and safety. Tumor response will be monitored using established criteria, and treatment allocation depends on the study design. Eligible patients are adults up to 75 years with good liver function and adequate organ performance who have measurable disease and no extrahepatic metastasis.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Jiayue Li
• Email: pumchkyc@126.com
• Phone: 010-69156874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.