Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)
This trial has been completed.
|Treatment||ablation with the nanoknife low energy direct current (ledc) system|
|Start date||February 2010|
|End date||January 2013|
|Trial size||26 participants|
|Trial identifier||NCT01078415, ONC-205|
The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Villejuif, France||L'institut de cancerologie Gustave Roussy||completed|
|Paris, France||Hopital Beaujon||completed|
|Magdeburg, Germany||Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin||completed|
|Pisa, Italy||University of Pisa School of Medicine||completed|
|Naples, Italy||Istituto Nazionale Tumori - Fondazione Pascale||completed|
|Barcelona, Spain||Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
time frame: 30 days (+/- 3 days) post treatment
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
time frame: Immediately post treatment to 2 years post treatment
Male or female participants at least 18 years old.
- HCC 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 ≤ 3 cm in diameter,
- Child-Pugh class A,
- Eastern Cooperative Oncology Group (ECOG) score of 0,
- American Society of Anaesthesiologists (ASA) score ≤ 3,
- a prothrombin time ratio > 50%,
- platelet count > 50x109/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.
- eligible for surgical treatment or transplantation for HCC,
- presence of vascular invasion or extrahepatic metastases,
- received previous treatment for HCC,
- HCC 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.
|Official title||A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)|
|Principal investigator||Riccardo Lencioni, MD|
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