OncoMatch/Clinical Trials/NCT07832006
Irreversible Electroporation Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Official title: A Prospective Study of Irreversible Electroporation Combined With Lenvatinib and Sintilimab for Conversion Therapy in Patients With Advanced Hepatocellular Carcinoma
Is NCT07832006 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Lenvatinib and Sintilimab for hepatocellular carcinoma (hcc).
Treatment: Lenvatinib · Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage IIA, IIB, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: irreversible electroporation
Previous treatment with irreversible electroporation
Cannot have received: systemic therapy that precludes treatment with lenvatinib or sintilimab
Prior systemic therapy that precludes treatment with lenvatinib or sintilimab
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥75 × 10⁹/L; hemoglobin ≥80 g/L
Kidney function
serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min
Liver function
Child-Pugh class A or B liver function; total bilirubin ≤3 × ULN; ALT and AST ≤5 × ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07832006 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irreversible electroporation, systemic therapy that precludes treatment with lenvatinib or sintilimab disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages