International Study on Treatment of Liver (HCC) Patients With IRE (LIVERHCC-IRE)

AngioDynamics

Status: Not yet enrolling

Conditions: Liver Cancer, Adult; Liver Ablation; Hepatocellular Carcinoma (HCC)

Treatments: Device: Irreversible Electroporation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07192731

2025-ONC-02

Details and patient eligibility

About

Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.
• Child-Pugh A up to A6.
• Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
• Rockwood Frailty Score ≤ 3.
• Serum bilirubin < 30 µmol/L.
• Serum creatinine < 150 µmol/L.
• No extrahepatic metastases
• IRE can be used for up to 3 tumours < 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.

Exclusion criteria

General:

• Patients involved in other research studies.
• Patients under the age of 18 years.
• Inability to give informed consent.
• Patients who are pregnant.
• Child-Pugh B or C.
• Patients with an ECOG status of > 2 at time of recruitment.
• Rockwood Frailty Score > 3
• Impaired renal function (serum creatinine > 150 µmol/L)
• Accepted exclusions to IRE from consensus criteria including:
• Platelet count < 50x109 U/L.
• International normalised ratio (INR) for blood clotting > 1.7.
• Prior hepatic tumour ablation.

Cardiovascular fitness related exclusions:

• History of ventricular arrhythmia.
• Implanted pacemaker or defibrillator.
• Congestive cardiac failure NYHA Class ≥ 3.

Tumour-related exclusions:

• Tumour ≥ 3 cm in size.
• Extrahepatic metastatic disease.
• Jaundice (serum bilirubin > 30 µmol/L).
• MDT recommends use of thermal ablation for any given lesion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Other: Use of NanoKnife System for ablation of HCC lesions

Experimental group

Treatment:

Device: Irreversible Electroporation