Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

NCT02425059 | Completed DMC

• 1 other identifier: Rectal cancer-IRE-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Neoplasms

Keywords

irreversible electroporation; Unresectable Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse events

  6 month

Secondary Outcomes (1)

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

  12 months

Other Outcomes (3)

• A minimum and maximum range of voltage for safe and effective IRE

  3 months

• Progress free disease (PFS)

  12 months

• Overall survival (OS)

  36 mouths

Study Arms (2)

IRE Group

EXPERIMENTAL

irreversible electroporation for Unresectable Rectal Neoplasms

Procedure: Irreversible electroporation (IRE); Device: NanoKnife

Control

NO INTERVENTION

The patients without treatment

Interventions

Irreversible electroporation (IRE) PROCEDURE

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

IRE Group

NanoKnife DEVICE

IRE Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Lizhi Niu, PhD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 23, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2019-04

Locations

CN (1)