International Study on Treatment of Liver (HCC) Patients With IRE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAngiodynamics, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients involved in other research studies.
Patients under the age of 18 years.
Inability to give informed consent.
Patients who are pregnant.
Trial design
Design model
Single group
Treatments tested in this trial
Irreversible Electroporation
DeviceIrreversible 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Other: Use of NanoKnife System for ablation of HCC lesionsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Complications of IRE: Episode-related complications:
Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI)
Time frame
30 days2
Complications of IRE: Intervention for local liver-related complications of IRE
Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical.
Time frame
12 months3
Oncological outcomes: Incomplete ablation requiring further intervention
Re-ablation and modality.
Time frame
6 months4
Oncological Outcome: Progression at site of ablation
Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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