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Completed

NCT Number: NCT02425059

Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

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

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 NanoKnife™ LEDC System,
  • Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Treatment and study plan

Irreversible electroporation (IRE)

Procedure

Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.

NanoKnife

Device

Primary outcomes

  1. Number of participants with Adverse events

    Time frame: 6 month

Secondary outcomes

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

    Time frame: 12 months

Other outcomes

  1. 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.

  2. Progress free disease (PFS)

    Time frame: 12 months

  3. Overall survival (OS)

    Time frame: 36 mouths

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

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Apr 23, 2015
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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