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

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShunda Du

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Irreversible Electroporation

    Procedure/Surgery

    Percutaneous or intraoperative irreversible electroporation performed according to institutional standards.

  • Lenvatinib

    Drug

    Oral administration according to body weight and prescribing information.

  • Sintilimab

    Drug

    200 mg intravenously every 3 weeks.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: IRE + Lenvatinib + SintilimabExperimental treatment 3 interventions
Group B: Lenvatinib + SintilimabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.

Time frame
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.
2

Conversion Surgery Rate

Proportion of patients who undergo curative-intent surgical resection after study treatment based on multidisciplinary evaluation.

Time frame
From treatment initiation until curative-intent conversion surgery, disease progression, or treatment discontinuation, whichever occurs first, assessed up to 24 months.

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from treatment initiation to disease progression or death.

Time frame
Up to 24 months
2

Overall Survival (OS)

Time from treatment initiation to death from any cause.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shunda Du

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov
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