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Not yet recruiting NCT07192731

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

No phase Interventional Hepatocellular Carcinoma (HCC) Liver Ablation Liver Cancer, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irreversible Electroporation.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC), Liver Ablation, Liver Cancer, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatment of LIVER-limited HepatoCellular Carcinoma (HCC) in Patients With Preserved Liver Function by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study

Overview

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

Interventions

  • Device Irreversible Electroporation
    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 th

Primary outcome measures

  • Target Tumour Eradication [Time frame: 6 months]
Secondary outcome measures (11)
  • Complications of IRE: Episode-related complications: [Time frame: 30 days]
  • Complications of IRE: Intervention for local liver-related complications of IRE [Time frame: 12 months]
  • Oncological outcomes: Incomplete ablation requiring further intervention [Time frame: 6 months]
  • Oncological Outcome: Progression at site of ablation [Time frame: 12 months]
  • Oncological outcome: Further anti-cancer intervention [Time frame: 12 months]
  • Oncological Outcome: Survival (Progression-free & overall) [Time frame: 12 months]
  • Oncologic Outcomes: local progression [Time frame: 12 months]
  • Oncologic Outcomes: Chemotherapy post-IRE [Time frame: 6 months]
  • Quality of life: EQ-5D-5 pre-procedure [Time frame: within 7 days prior to procedure]
  • Quality of life: EQ-5D-5 post-procedure 7 days [Time frame: 7 days]
  • Quality of life: EQ-5D-5 - 6 months [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Manchester Royal Infirmiary — Manchester

Identifiers

NCT: NCT07192731 · 2025-ONC-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗