IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus

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. 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.

Eligibility

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

Conditions2

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