Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function

Not Applicable

Completed

• Conditions: Hepatic Carcinoma
• Interventions: Device: NanoKnife LEDC System

• Registration Number: NCT02352935
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Status Verified: 2019-04
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NanoKnife LEDC System	NanoKnife LEDC System	90 pulses of 70 microseconds each in duration will be administered per electrode pair

Primary Outcome Measures

Name	Time	Method
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.	1 day post treatment to 14 days post treatment

Secondary Outcome Measures

Name	Time	Method
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.	30 days (+/- 3 days) post treatment

Trial Locations

Locations (1)

FUDA Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China