Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425059
• Other study ID #: Rectal cancer-IRE-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Rectal Neoplasms

Intervention

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

Device:
• NanoKnife

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	A minimum and maximum range of voltage for safe and effective IRE	A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.	3 months
Other	Progress free disease (PFS)		12 months
Other	Overall survival (OS)	Patients will be followed for 36 months after IRE for OS analyzed.	36 mouths
Primary	Number of participants with Adverse events		6 month
Secondary	Percentage of lesions that show no sign of recurrence 12 months after IRE		12 months