Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IRE | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRE | Other | — | UNRESOLVED |
| PLACEBO | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IRE + chemotherapy continuation
- interventionNames
- Other: IRE
- type
- PLACEBO_COMPARATOR
- label
- chemotherapy continuation alone
- interventionNames
- Other: PLACEBO
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- Up to 48 months
- description
- Time from first antitumor treatment to death from any cause
- measure
- Progression-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available