search
Back to results

Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Irreversible electroporation (IRE)
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver cancer diagnosed by positive biopsy or non-invasive criteria,
  • Tumors from diaphragm is <1 cm
  • not suitable for surgical resection or transplantation,
  • have at least one, but less than or equal to 3 tumors,
  • of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
  • Child-Pugh class A,B
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • a prothrombin time ratio > 50%,
  • platelet count > 80x109/L,
  • ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  • are able to comprehend and willing to sign the written informed consent form (ICF),
  • have a life expectancy of at least 3 months.

Exclusion Criteria:

  • liver cancer developed on an already transplanted liver,
  • 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.

Sites / Locations

  • FUDA Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NanoKnife LEDC System

Control

Arm Description

Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair.

The patients without treatment

Outcomes

Primary Outcome Measures

Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
Safety using Common terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures

Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC)
Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.

Full Information

First Posted
December 26, 2014
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
search

1. Study Identification

Unique Protocol Identification Number
NCT02329106
Brief Title
Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
Official Title
Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
Detailed Description
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome. This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated. To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoKnife LEDC System
Arm Type
Experimental
Arm Description
Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients without treatment
Intervention Type
Device
Intervention Name(s)
Irreversible electroporation (IRE)
Other Intervention Name(s)
NanoKnife
Intervention Description
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome.
Primary Outcome Measure Information:
Title
Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
Description
Safety using Common terminology Criteria for Adverse Events (CTCAE).
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC)
Description
Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver cancer diagnosed by positive biopsy or non-invasive criteria, Tumors from diaphragm is <1 cm not suitable for surgical resection or transplantation, have at least one, but less than or equal to 3 tumors, of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter, Child-Pugh class A,B Eastern Cooperative Oncology Group (ECOG) score of 0-1, a prothrombin time ratio > 50%, platelet count > 80x109/L, ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, are able to comprehend and willing to sign the written informed consent form (ICF), have a life expectancy of at least 3 months. Exclusion Criteria: liver cancer developed on an already transplanted liver, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, M.D.,PHD.
Organizational Affiliation
President
Official's Role
Study Chair
Facility Information:
Facility Name
FUDA Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

Learn more about this trial

Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

We'll reach out to this number within 24 hrs