Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms

Overview

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

Full Title of Study: “Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms: Phase I and Phase II Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 1, 2020

Detailed Description

By enrolling patients with unresectable Urinary Bladder 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 Urinary Bladder Neoplasms.

Interventions

  • Procedure: Irreversible electroporation (IRE)
    • Irreversible Electroportion For Unresectable Urinary Bladder Neoplasms guide with ultrasound or/and CT.
  • Device: NanoKnife

Arms, Groups and Cohorts

  • Experimental: IRE Group
    • irreversible electroporation for Unresectable Urinary Bladder Neoplasms
  • No Intervention: Control
    • The patients without treatment

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with Adverse events
    • Time Frame: 6 month

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Head and Urinary Bladder 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 > 80×10^9/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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lizhi Niu, PhD, Study Chair, Fuda Cancer Hospital

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