search
Back to results

Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli (IRE)

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Irreversible electroporation (IRE)
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring irreversible electroporation, Portal venous tumor emboli

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fuda Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

irreversible electroporation with voltage in level A for Unresectable Portal Venous Tumor Emboli

irreversible electroporation with voltage in level B for Unresectable Portal Venous Tumor Emboli

irreversible electroporation with voltage in level C for Unresectable Portal Venous Tumor Emboli

Outcomes

Primary Outcome Measures

Safety (adverse effects)
adverse effects

Secondary Outcome Measures

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）
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.
Progress free disease (PFS)
Patients will be followed for 12 months after IRE for PFS assessing.
Overall survival (OS)
Patients will be followed for 36 months after IRE for OS analyzed.

Full Information

First Posted
January 6, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
search

1. Study Identification

Unique Protocol Identification Number
NCT02333773
Brief Title
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli
Acronym
IRE
Official Title
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
irreversible electroporation, Portal venous tumor emboli

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level A for Unresectable Portal Venous Tumor Emboli
Arm Title
Group B
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level B for Unresectable Portal Venous Tumor Emboli
Arm Title
Group C
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level C for Unresectable Portal Venous Tumor Emboli
Intervention Type
Procedure
Intervention Name(s)
Irreversible electroporation (IRE)
Other Intervention Name(s)
NanoKnife
Intervention Description
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
Primary Outcome Measure Information:
Title
Safety (adverse effects)
Description
adverse effects
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)
Description
The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE）
Time Frame
12 months
Title
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
Description
A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
Time Frame
3 months
Title
Progress free disease (PFS)
Description
Patients will be followed for 12 months after IRE for PFS assessing.
Time Frame
12 months
Title
Overall survival (OS)
Description
Patients will be followed for 36 months after IRE for OS analyzed.
Time Frame
36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PHD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuda Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

Learn more about this trial

Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli

We'll reach out to this number within 24 hrs