Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli

Not Applicable

Completed

• Conditions: Liver Cancer

• Registration Number: NCT02333773
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.

Detailed Description

By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Status Verified: 2019-05
• 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

• Liver cancer diagnosed by positive biopsy or non-invasive criteria,
• Liver cancer with Portal venous tumor emboli,
• Not suitable for surgical resection or transplantation,
• Child-Pugh class A,B
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• A prothrombin time ratio > 50%,
• Platelet count > 80x10^9/L,
• Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
• Able to comprehend and willing to sign the written informed consent form (ICF),
• Have a life expectancy of at least 3 months.

Exclusion Criteria

• 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

Primary Outcome Measures

Name	Time	Method
Safety (adverse effects)	6 month	adverse effects

Secondary Outcome Measures

Name	Time	Method
Progress free disease (PFS)	12 months	Patients will be followed for 12 months after IRE for PFS assessing.
Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)	12 months	The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE）
Voltage (A minimum and maximum range of voltage for safe and effective IRE)	3 months	A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
Overall survival (OS)	36 months	Patients will be followed for 36 months after IRE for OS analyzed.

Trial Locations

Locations (1)

Fuda Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China