Status:
NOT_YET_RECRUITING
International Study on Treatment of Liver (HCC) Patients With IRE
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Hepatocellular Carcinoma (HCC)
Liver Ablation
Eligibility:
All Genders
18+ years
Phase:
NA
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 irreve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07192731
Start Date
February 1 2026
End Date
February 1 2029
Last Update
October 10 2025
Active Locations (1)
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1
Manchester Royal Infirmiary
Manchester, United Kingdom, M13 9WL