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

NCT07192731 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-ONC-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

irreversible electroporation; liver ablation; nanoknife; liver ire registry

Outcome Measures

Primary Outcomes (1)

• Target Tumour Eradication

  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.

  6 months

Secondary Outcomes (11)

• Complications of IRE: Episode-related complications:

  30 days

• Complications of IRE: Intervention for local liver-related complications of IRE

  12 months

• Oncological outcomes: Incomplete ablation requiring further intervention

  6 months

• Oncological Outcome: Progression at site of ablation

  12 months

• Oncological outcome: Further anti-cancer intervention

  12 months

Study Arms (1)

Other: Use of NanoKnife System for ablation of HCC lesions

EXPERIMENTAL

Device: Irreversible Electroporation

Interventions

Irreversible Electroporation DEVICE

Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death. IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Also known as: nanoknife

Other: Use of NanoKnife System for ablation of HCC lesions

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Platelet count \< 50x109 U/L.
• International normalised ratio (INR) for blood clotting \> 1.7.
• Prior hepatic tumour ablation.
• History of ventricular arrhythmia.
• Implanted pacemaker or defibrillator.
• Congestive cardiac failure NYHA Class ≥ 3.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (1)

Manchester Royal Infirmiary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Ajith Siriwardena, MD FRCS

  Manchester Royal Infirmiary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Vanderpoll

CONTACT

+44 7790921819; mvanderpoll@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an international, prospective, multi-centre, registry-based, non-randomized, single arm clinical cohort study of the use of IRE for the treatment of HCC

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: September 25, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

GB (1)