IRE after targeted immunotherapy in HCC with portal vein tumor thrombus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective randomized Phase II study enrolling about 60 adults with hepatocellular carcinoma and portal vein tumor thrombus who have not progressed after three cycles of target-immunotherapy. Participants are assigned in a 2:1 ratio to receive either open or percutaneous IRE plus continuation of the original immunotherapy or continuation of immunotherapy alone. Outcomes include overall survival, progression-free survival, tumor response, quality of life, safety, and postoperative metrics. Eligibility requires unresectable disease or inability to tolerate resection, measurable lesions, adequate organ function, and no prior palliative targeted immunotherapy. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital and Tianjin Cancer Hospital Airport Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where it's running

• Tianjin Cancer Hospital Airport Hospital
  Tianjin, Tianjin Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.