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

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ClinicalTrials.gov Identifier: NCT02430701
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Procedure: Irreversible electroporation (IRE) Device: NanoKnife Phase 1 Phase 2

Detailed Description:
By enrolling patients with unresectable Esophageal 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 Esophageal Neoplasms.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation(IRE) For Unresectable Esophageal Neoplasms: Phase I and Phase II Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IRE Group
irreversible electroporation for Unresectable Esophageal Neoplasms
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Esophageal Neoplasms guide with ultrasound or/and CT.
Other Name: NanoKnife

Device: NanoKnife



Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]
  2. A minimum and maximum range of voltage for safe and effective IRE [ Time Frame: 3 months ]
    A minimum and maximum range of voltage for safe and effective IRE will be

  3. Progress free disease (PFS) [ Time Frame: 12 months ]
  4. Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Esophageal 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430701


Contacts
Contact: Lizhi Niu, PhD niuboshi@fudahospital.com

Locations
China, Guangdong
Biological treatment center in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China
Contact: Chen Jibing, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital

Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02430701     History of Changes
Other Study ID Numbers: Esophageal Neoplasms -IRE-01
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Fuda Cancer Hospital, Guangzhou:
irreversible electroporation
Unresectable Esophageal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases