Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli

Overview

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.

Full Title of Study: “Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: 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 Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.

Interventions

  • Procedure: Irreversible electroporation (IRE)
    • Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.

Arms, Groups and Cohorts

  • Experimental: Group A
    • irreversible electroporation with voltage in level A for Unresectable Portal Venous Tumor Emboli
  • Experimental: Group B
    • irreversible electroporation with voltage in level B for Unresectable Portal Venous Tumor Emboli
  • Experimental: Group C
    • irreversible electroporation with voltage in level C for Unresectable Portal Venous Tumor Emboli

Clinical Trial Outcome Measures

Primary Measures

  • Safety (adverse effects)
    • Time Frame: 6 month
    • adverse effects

Secondary Measures

  • Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)
    • Time Frame: 12 months
    • The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)
  • Voltage (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 analyzed for optimal choice.
  • Progress free disease (PFS)
    • Time Frame: 12 months
    • Patients will be followed for 12 months after IRE for PFS assessing.
  • 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

  • Liver cancer diagnosed by positive biopsy or non-invasive criteria,
  • Liver cancer with Portal venous tumor emboli,
  • Not suitable for surgical resection or transplantation,
  • Child-Pugh class A,B
  • 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
  • Overall Contact(s)
    • Zhikai Zhang, PHD, zzk001198@163.com

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