Clinical trial · Interventional
Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function
Hepatic Carcinoma in Poor Liver Function: Safety and Efficacy of Irreversible Electroporation (IRE)
NCT02352935CI-TRIAL-00053679completedN/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)
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoKnife LEDC System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NanoKnife LEDC System
- description
- 90 pulses of 70 microseconds each in duration will be administered per electrode pair
- interventionNames
- Device: NanoKnife LEDC System
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients without any treatment
Primary outcomes (1)
- measure
- Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
- timeFrame
- 1 day post treatment to 14 days post treatment
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter, * Child-Pugh class B or ≤12， * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * American Society of Anaesthesiologists (ASA) score ≤ 3, * a prothrombin time ratio \> 50%, * platelet count \> 80x109/L, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * are able to comprehend and willing to sign the written informed consent form (ICF), * have a life expectancy of at least 3 months. Exclusion Criteria: * eligible for surgical treatment or transplantation for HCC, * Hepatic carcinoma developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg Pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
References
Publications (0)
Data not yet available
No reference posted for this study.