IRENCT07799922
IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus
A study testing IRE in people with IRE, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with hepatocellular carcinoma and portal vein tumor thrombus who have received three cycles of target-immunotherapy induction and have non-progressive disease will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IRE
- What is being tested?
- IRE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 31 Dec 2028
- Phase
- Interventional
- 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 18-75 years, any sex
- Imaging-confirmed or histologically confirmed primary liver cancer/hepatocellular carcinoma (HCC)
- After three cycles of target-immunotherapy induction, MDT review determines unresectable disease or inability to tolerate surgical resection
- Willingness to receive standard conversion treatment
- No prior palliative targeted immunotherapy or other systemic antitumor therapy
- Maximum tumor diameter <=5 cm and number of tumors <=5
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- No extrahepatic metastasis; portal vein tumor thrombus Vp1-3
- At least one measurable lesion according to RECIST 1.1
- Adequate organ and marrow function: hemoglobin >=9.0 g/dL; neutrophils >=1.5 x 10^9/L; platelets >=100 x 10^9/L; TBIL <=3 x ULN; AST and ALT <=5.0 x ULN; serum creatinine <=1.5 x ULN or CrCl >60 mL/min by Cockcroft-Gault formula
- ECOG Performance Status 0-1
- Expected survival of at least 3 months
- Patients of childbearing potential and their partners agree to use contraception
- Voluntary written informed consent
Who cannot join
- Refusal to receive systemic therapy or possible surgery
- Metastasis to other sites, such as lymph nodes, peritoneum, lung, bone, or brain
- History of other malignancies, except cured basal cell carcinoma of the skin or cervical carcinoma in situ
- Severe uncontrolled comorbidities, including uncontrolled congestive heart failure (NYHA III/IV), unstable angina, poorly controlled arrhythmia, uncontrolled hypertension, active infection, uncontrolled diabetes, uncontrolled pleural effusion/pericardial effusion/ascites requiring drainage, severe portal hypertension or portal cavernoma on imaging, gastric outlet obstruction, or respiratory insufficiency requiring oxygen
- Major surgery within 30 days before screening
- EGFR monoclonal antibody or EGFR-TKI within 30 days before screening
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- Allergy to any drug or component used in this protocol
- Known or self-reported HIV infection or chronic hepatitis B or hepatitis C
- Unresolved toxicity >=CTCAE grade 2 from prior treatment, except anemia, alopecia, skin pigmentation, or chemotherapy-induced neurotoxicity
- Any other reason judged by the investigator to make participation inappropriate
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
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Li Huikai, MD, 18622228639, tjchlhk@126.com
About this study
Official title: A Prospective, Randomized Controlled Phase II Clinical Study of Sequential or Non-sequential Irreversible Electroporation After Targeted Immunotherapy Induction in Patients With Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with hepatocellular carcinoma and portal vein tumor thrombus who have received three cycles of target-immunotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable or unable to tolerate surgical resection by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.
- Conditions
- IRE
- Being tested
- IRE, PLACEBO
- Keywords
- IRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IREOther
undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen
PLACEBOOther
the original treatment regimen alone
| Study group | Role | What they receive |
|---|---|---|
| IRE + chemotherapy continuation | Experimental | Not described Receives: Other: IRE |
| chemotherapy continuation alone | Placebo comparator | Not described Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from first antitumor treatment to death from any cause
Measured: Up to 48 months
Progression-Free Survival
Time from randomization to first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.
Measured: Up to 48 months
Secondary outcomes (2)
Disease Control Rate
Proportion of participants achieving complete response, partial response, or stable disease per RECIST 1.1.
Measured: Up to 48 months
Objective Response Rate
Proportion of participants achieving complete response or partial response per RECIST 1.1.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start20 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IREStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799922
- Sponsor's protocol ID
- HCCNANO-HOPE1
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Phase II Clinical Study of Sequential or Non-sequential Irreversible Electroporation After Targeted Immunotherapy Induction in Patients With Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT07799922
- Acronym / sponsor ID
- HCCNANO-HOPE1
- Conditions
- IRE
- Keywords
- IRE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 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.
This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with hepatocellular carcinoma and portal vein tumor thrombus who have received three cycles of target-immunotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable or unable to tolerate surgical resection by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE + chemotherapy continuation | Experimental | Other: IRE |
| chemotherapy continuation alone | Placebo comparator | Other: PLACEBO |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years, any sex
- Imaging-confirmed or histologically confirmed primary liver cancer/hepatocellular carcinoma (HCC)
- After three cycles of target-immunotherapy induction, MDT review determines unresectable disease or inability to tolerate surgical resection
- Willingness to receive standard conversion treatment
- No prior palliative targeted immunotherapy or other systemic antitumor therapy
Key exclusion criteria (10 listed)
- Refusal to receive systemic therapy or possible surgery
- Metastasis to other sites, such as lymph nodes, peritoneum, lung, bone, or brain
- History of other malignancies, except cured basal cell carcinoma of the skin or cervical carcinoma in situ
- Severe uncontrolled comorbidities, including uncontrolled congestive heart failure (NYHA III/IV), unstable angina, poorly controlled arrhythmia, uncontrolled hypertension, active infection, uncontrolled diabetes, uncontrolled pleural effusion/pericardial effusion/ascites requiring drainage, severe portal hypertension or portal cavernoma on imaging, gastric outlet obstruction, or respiratory insufficiency requiring oxygen
- Major surgery within 30 days before screening
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 |
|---|---|---|
| IREundergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen | Other | IRE + chemotherapy continuation |
| PLACEBOthe original treatment regimen alone | Other | chemotherapy continuation alone |
Primary outcome
Overall Survival
Time frame: Up to 48 months
Time from first antitumor treatment to death from any cause
Progression-Free Survival
Time frame: Up to 48 months
Time from randomization to first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.
2 secondary outcomes
Disease Control Rate
Time frame: Up to 48 months
Objective Response Rate
Time frame: Up to 48 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 2 Sep 2026.
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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 study testing IRE in people with IRE, run by Tianjin Medical University Cancer Institute and Hospital 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 13 inclusion and 10 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 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 48 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 2 Sep 2026.