- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333773
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli (IRE)
September 1, 2021 updated by: Fuda Cancer Hospital, Guangzhou
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510665
- Fuda Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 > 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
irreversible electroporation with voltage in level A for Unresectable Portal Venous Tumor Emboli
|
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
Other Names:
|
Experimental: Group B
irreversible electroporation with voltage in level B for Unresectable Portal Venous Tumor Emboli
|
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
Other Names:
|
Experimental: Group C
irreversible electroporation with voltage in level C for Unresectable Portal Venous Tumor Emboli
|
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (adverse effects)
Time Frame: 6 month
|
adverse effects
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 36 months
|
Patients will be followed for 36 months after IRE for OS analyzed.
|
36 months
|
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.
|
3 months
|
Progress free disease (PFS)
Time Frame: 12 months
|
Patients will be followed for 12 months after IRE for PFS assessing.
|
12 months
|
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)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
January 6, 2015
First Submitted That Met QC Criteria
January 6, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZhangZhikai-IRE-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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