Clinical trial · Interventional
International Study on Treatment of Liver (HCC) Patients With IRE
Treatment of LIVER-limited HepatoCellular Carcinoma (HCC) in Patients With Preserved Liver Function by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study
NCT07192731CI-TRIAL-00096494LIVERHCC-IREnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Ablation | — | UNRESOLVED | — |
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible Electroporation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Other: Use of NanoKnife System for ablation of HCC lesions
- interventionNames
- Device: Irreversible Electroporation
Primary outcomes (1)
- measure
- Target Tumour Eradication
- timeFrame
- 6 months
- description
- 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 outcomes (11)
- measure
- Complications of IRE: Episode-related complications:
- timeFrame
- 30 days
- description
- Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.