IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus

NCT07799922 | Recruiting

• 1 other identifier: HCCNANO-HOPE1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IRE

Keywords

IRE

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time from first antitumor treatment to death from any cause

  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.

  Up to 48 months

Secondary Outcomes (2)

• Disease Control Rate

  Up to 48 months

• Objective Response Rate

  Up to 48 months

Study Arms (2)

IRE + chemotherapy continuation

EXPERIMENTAL

Other: IRE

chemotherapy continuation alone

PLACEBO COMPARATOR

Other: PLACEBO

Interventions

IRE OTHER

undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen

IRE + chemotherapy continuation

PLACEBO OTHER

the original treatment regimen alone

chemotherapy continuation alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)