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Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

Primary Purpose

Rectal Neoplasms

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

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring irreversible electroporation, Unresectable Rectal Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria,
  • Not suitable for surgical resection,
  • 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

  • Biological treatment center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IRE Group

Control

Arm Description

irreversible electroporation for Unresectable Rectal Neoplasms

The patients without treatment

Outcomes

Primary Outcome Measures

Number of participants with Adverse events

Secondary Outcome Measures

Percentage of lesions that show no sign of recurrence 12 months after IRE

Full Information

First Posted
April 15, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02425059
Brief Title
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms
Official Title
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
February 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 Rectal Neoplasms.
Detailed Description
By enrolling patients with unresectable Rectal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Rectal Neoplasms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
irreversible electroporation, Unresectable Rectal Neoplasms

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IRE Group
Arm Type
Experimental
Arm Description
irreversible electroporation for Unresectable Rectal Neoplasms
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients without treatment
Intervention Type
Procedure
Intervention Name(s)
Irreversible electroporation (IRE)
Intervention Description
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
Intervention Type
Device
Intervention Name(s)
NanoKnife
Primary Outcome Measure Information:
Title
Number of participants with Adverse events
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Percentage of lesions that show no sign of recurrence 12 months after IRE
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
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)
Time Frame
12 months
Title
Overall survival (OS)
Description
Patients will be followed for 36 months after IRE for OS analyzed.
Time Frame
36 mouths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria, Not suitable for surgical resection, 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
Biological treatment center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

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