Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli

Liver Cancer Clinical Trial

— IRE  

Official title:

Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333773
• Other study ID #: ZhangZhikai-IRE-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Liver Cancer

Intervention

Procedure:
• Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.

Locations

Country	Name	City	State
China	Fuda Cancer Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse effects)	adverse effects	6 month
Secondary	Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)	The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)	12 months
Secondary	Voltage (A minimum and maximum range of voltage for safe and effective IRE)	A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.	3 months
Secondary	Progress free disease (PFS)	Patients will be followed for 12 months after IRE for PFS assessing.	12 months
Secondary	Overall survival (OS)	Patients will be followed for 36 months after IRE for OS analyzed.	36 months