💬In plain words
What the trial is, and whether it could suit you
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 endpoin
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Irreversible Electroporation
- Lenvatinib
- Sintilimab
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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