Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)

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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.