Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function

NCT ID: NCT02352935

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2021-01-01

Brief Summary

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.

Detailed Description

Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

Conditions

Hepatic Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NanoKnife LEDC System

90 pulses of 70 microseconds each in duration will be administered per electrode pair

Group Type: EXPERIMENTAL

NanoKnife LEDC System

Intervention Type: DEVICE

90 pulses of 70 microseconds each in duration will be administered per electrode pair

Control

The patients without any treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NanoKnife LEDC System

90 pulses of 70 microseconds each in duration will be administered per electrode pair

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhi l Niu

Role: STUDY_CHAIR

FUDA Cancer Hospital

Locations

FUDA Cancer Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

JF-20150127（5）

Identifier Type: -

Identifier Source: org_study_id