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Zapping liver tumors to make them operable

NCT ID NCT07832006

NEW Disease control Sponsor: Shunda Du Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers test whether irreversible electroporation, a technique that uses electrical pulses to destroy tumor cells while sparing nearby blood vessels and bile ducts, can boost the effects of lenvatinib and sintilimab in people with advanced hepatocellular carcinoma that cannot be surgically removed. Participants receive the drug combination with or without the electroporation procedure. The study measures how many tumors shrink and how many patients become eligible for curative surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
irreversible electroporation combined with lenvatinib and sintilimab
What this could lead to
If it works, this approach could make surgery possible for more people whose liver cancer cannot be removed at diagnosis.
What could go wrong
The trial is small and single-center, so results may not apply broadly. Combining ablation with drugs and immunotherapy can cause liver injury, bleeding, or immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, 100730, China

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