Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT02425059
Collaborator
(none)
30
1
2
73
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Irreversible electroporation (IRE)
  • Device: NanoKnife
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: IRE Group

irreversible electroporation for Unresectable Rectal Neoplasms

Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.

Device: NanoKnife

No Intervention: Control

The patients without treatment

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Adverse events [6 month]

Secondary Outcome Measures

  1. Percentage of lesions that show no sign of recurrence 12 months after IRE [12 months]

Other Outcome Measures

  1. 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.

  2. Progress free disease (PFS) [12 months]

  3. Overall survival (OS) [36 mouths]

    Patients will be followed for 36 months after IRE for OS analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 NanoKnifeā„¢ LEDC System,

  • Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biological treatment center in Fuda cancer hospital Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Fuda Cancer Hospital, Guangzhou

Investigators

  • Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier:
NCT02425059
Other Study ID Numbers:
  • Rectal cancer-IRE-01
First Posted:
Apr 23, 2015
Last Update Posted:
Sep 5, 2021
Last Verified:
Apr 1, 2019
Keywords provided by Fuda Cancer Hospital, Guangzhou
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021