Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

Fuda Cancer Hospital, Guangzhou

Status: Completed

Conditions: Liver Cancer

Treatments: Device: Irreversible electroporation (IRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02329106

JF-20141225

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.

Full description

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.

This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.

To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver cancer diagnosed by positive biopsy or non-invasive criteria,
• Tumors from diaphragm is <1 cm
• 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 A,B
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• 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

• liver cancer 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

NanoKnife LEDC System

Experimental group

Description:

Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Treatment:

Device: Irreversible electroporation (IRE)

Control

No Intervention group

Description:

The patients without treatment