Hepatocellular Carcinoma (HCC)Phase 2NCT07832006
Irreversible Electroporation Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
A Phase 2 study testing Irreversible Electroporation, Lenvatinib and Sintilimab in people with Hepatocellular Carcinoma (HCC), run by Shunda Du at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Irreversible Electroporation, Lenvatinib and Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China, 100730
Longfang Miao, 010-69155709, pumchjyc@126.com
About this study
Official title: A Prospective Study of Irreversible Electroporation Combined With Lenvatinib and Sintilimab for Conversion Therapy in Patients With Advanced Hepatocellular Carcinoma
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.
Read the detailed description
- Background Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. For patients with advanced-stage disease, systemic therapy based on tyrosine kinase inhibitors and immune checkpoint inhibitors has become the standard of care. However, only a proportion of patients achieve meaningful tumor regression, and the rate of successful conversion to surgical resection remains limited. Irreversible electroporation (IRE) is a novel non-thermal local ablative technique that induces apoptosis through permanent disruption of cellular membranes. Unlike thermal ablation modalities, IRE preserves major blood vessels and bile ducts, making it particularly suitable for tumors adjacent to critical structures. Furthermore, preclinical and clinical studies have suggested that IRE may induce immunogenic cell death and augment anti-tumor immune responses.
- Study Objectives The primary objective of this study is to evaluate whether the addition of IRE to targeted therapy and immunotherapy improves tumor response and conversion surgery rate in patients with advanced HCC. The secondary objective is to assess survival outcomes and treatment-related safety.
- Study Design
This is a prospective, single-center, open-label interventional study. Patients with advanced HCC meeting the eligibility criteria will receive either:
IRE combined with lenvatinib and sintilimab; or Lenvatinib and sintilimab alone.
Tumor response will be evaluated according to RECIST version 1.1 and mRECIST criteria. Patients will undergo regular imaging assessments and multidisciplinary evaluation to determine eligibility for curative-intent surgical resection.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Irreversible Electroporation, Lenvatinib, Sintilimab
- Keywords
- Hepatocellular Carcinoma, Irreversible Electroporation, Lenvatinib, Sintilimab, Conversion Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationProcedure or surgery
Percutaneous or intraoperative irreversible electroporation performed according to institutional standards.
LenvatinibDrug
Oral administration according to body weight and prescribing information.
SintilimabDrug
200 mg intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IRE + Lenvatinib + Sintilimab | Experimental | Patients receive irreversible electroporation combined with lenvatinib and sintilimab as conversion therapy. Receives: Procedure: Irreversible Electroporation; Drug: Lenvatinib; Drug: Sintilimab |
| Lenvatinib + Sintilimab | Active comparator | Patients receive standard targeted therapy and immunotherapy without IRE. Receives: Drug: Lenvatinib; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: 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.
Conversion Surgery Rate
Proportion of patients who undergo curative-intent surgical resection after study treatment based on multidisciplinary evaluation.
Measured: From treatment initiation until curative-intent conversion surgery, disease progression, or treatment discontinuation, whichever occurs first, assessed up to 24 months.
Secondary outcomes (2)
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death.
Measured: Up to 24 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Apr 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shunda Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shunda Du, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832006
- Sponsor's protocol ID
- I-24PJ2181
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Irreversible Electroporation Combined With Lenvatinib and Sintilimab for Conversion Therapy in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07832006
- Acronym / sponsor ID
- I-24PJ2181
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, Irreversible Electroporation, Lenvatinib, Sintilimab, Conversion Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shunda DuUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. For patients with advanced-stage disease, systemic therapy based on tyrosine kinase inhibitors and immune checkpoint inhibitors has become the standard of care. However, only a proportion of patients achieve meaningful tumor regression, and the rate of successful conversion to surgical resection remains limited. Irreversible electroporation (IRE) is a novel non-thermal local ablative technique that induces apoptosis through permanent disruption of cellular membranes. Unlike thermal ablation modalities, IRE preserves major blood vessels and bile ducts, making it particularly suitable for tumors adjacent to critical structures. Furthermore, preclinical and clinical studies have suggested that IRE may induce immunogenic cell death and augment anti-tumor immune responses.
- Study Objectives The primary objective of this study is to evaluate whether the addition of IRE to targeted therapy and immunotherapy improves tumor response and conversion surgery rate in patients with advanced HCC. The secondary objective is to assess survival outcomes and treatment-related safety.
- Study Design
This is a prospective, single-center, open-label interventional study. Patients with advanced HCC meeting the eligibility criteria will receive either:
IRE combined with lenvatinib and sintilimab; or Lenvatinib and sintilimab alone.
Tumor response will be evaluated according to RECIST version 1.1 and mRECIST criteria. Patients will undergo regular imaging assessments and multidisciplinary evaluation to determine eligibility for curative-intent surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE + Lenvatinib + Sintilimab | Experimental | Procedure: Irreversible Electroporation, Drug: Lenvatinib, Drug: SintilimabPatients receive irreversible electroporation combined with lenvatinib and sintilimab as conversion therapy. |
| Lenvatinib + Sintilimab | Active comparator | Drug: Lenvatinib, Drug: SintilimabPatients receive standard targeted therapy and immunotherapy without IRE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible ElectroporationPercutaneous or intraoperative irreversible electroporation performed according to institutional standards. | Procedure or surgery | IRE + Lenvatinib + Sintilimab |
| LenvatinibOral administration according to body weight and prescribing information. | Drug | IRE + Lenvatinib + Sintilimab, Lenvatinib + Sintilimab |
| Sintilimab200 mg intravenously every 3 weeks. | Drug | IRE + Lenvatinib + Sintilimab, Lenvatinib + Sintilimab |
Primary outcome
Objective Response Rate (ORR)
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.
The proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
Conversion Surgery Rate
Time frame: From treatment initiation until curative-intent conversion surgery, disease progression, or treatment discontinuation, whichever occurs first, assessed up to 24 months.
Proportion of patients who undergo curative-intent surgical resection after study treatment based on multidisciplinary evaluation.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irreversible Electroporation, Lenvatinib and Sintilimab in people with Hepatocellular Carcinoma (HCC), run by Shunda Du at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayue Li (010-69156874, pumchkyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.