NCT07799922Recruiting
IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Aug 2026
- Start date
- 20 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07799922
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 20 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refusal to receive systemic therapy or possible surgery
- Major surgery within 30 days before screening
- Unresolved toxicity \>=CTCAE grade 2 from prior treatment, except anemia, alopecia, skin pigmentation, or chemotherapy-induced neurotoxicity
Other illness
- 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
- Allergy to any drug or component used in this protocol
- Known or self-reported HIV infection or chronic hepatitis B or hepatitis C
Lab values
- EGFR monoclonal antibody or EGFR-TKI within 30 days before screening
Other
- Metastasis to other sites, such as lymph nodes, peritoneum, lung, bone, or brain
- Any other reason judged by the investigator to make participation inappropriate
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.