Irreversible Electroporation(IRE) For Unresectable Stomach Neoplasms (IRE)

September 1, 2021 updated by: Fuda Cancer Hospital, Guangzhou

Irreversible Electroporation(IRE) For Unresectable Stmoach Neoplasms: Phase I and Phase II Clinical Trial

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Stomach Neoplasms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By enrolling patients with unresectable Head and Stomach 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 Stomach Neoplasms.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Biological treatment center in Fuda cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stomach 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The patients without treatment
Experimental: IRE Group
irreversible electroporation for Unresectable Stomach Neoplasms
Device: NanoKnife
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Stomach Neoplasms guide with ultrasound or/and CT.
Other Names:
  • NanoKnife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse events
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of lesions that show no sign of recurrence 12 months after IRE
Time Frame: 12 months
12 months
Progress free disease (PFS)
Time Frame: 12 months
12 months
Overall survival (OS)
Time Frame: 36 months
Patients will be followed for 36 months after IRE for OS analyzed.
36 months
A minimum and maximum range of voltage for safe and effective IRE
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 26, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stomach Neoplasms -IRE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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