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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07192731
• Lead Sponsor: Angiodynamics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Study First Posted: 2025-09-25
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-10
• Study Start: 2026-02-01
• Primary Completion: 2028-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Target Tumour Eradication	6 months	The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria. This is based on a per-lesion analysis.

Secondary Outcome Measures

Name	Time	Method
Oncological Outcome: Survival (Progression-free & overall)	12 months	Progression-free and overall survival at 12 months from time of IRE.
Complications of IRE: Episode-related complications:	30 days	Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI)
Complications of IRE: Intervention for local liver-related complications of IRE	12 months	Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical.
Oncological outcomes: Incomplete ablation requiring further intervention	6 months	Re-ablation and modality.
Oncological outcome: Further anti-cancer intervention	12 months	Any further liver-directed, anti-cancer intervention including TACE and SIRT
Oncological Outcome: Progression at site of ablation	12 months	Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Oncologic Outcomes: Chemotherapy post-IRE	6 months	Any use of chemotherapy after IRE.
Quality of life: EQ-5D-5 pre-procedure	within 7 days prior to procedure	Effect of intervention on quality of life as assessed by EQ-5D-5
Quality of life: EQ-5D-5 post-procedure 7 days	7 days	Effect of intervention on quality of life as assessed by EQ-5D-5
Oncologic Outcomes: local progression	12 months	Local progression at site of IRE-treated lesion.
Quality of life: EQ-5D-5 - 6 months	6 months	Effect of intervention on quality of life as assessed by EQ-5D-5

Trial Locations

Locations (1)

Manchester Royal Infirmiary; 🇬🇧 Manchester, United Kingdom