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Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function

Primary Purpose

Hepatic Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NanoKnife LEDC System
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
  • 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 B or ≤12，
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • American Society of Anaesthesiologists (ASA) score ≤ 3,
  • 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:

  • eligible for surgical treatment or transplantation for HCC,
  • Hepatic carcinoma 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

90 pulses of 70 microseconds each in duration will be administered per electrode pair

The patients without any treatment

Outcomes

Primary Outcome Measures

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

Secondary Outcome Measures

Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

Full Information

First Posted
January 27, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02352935
Brief Title
Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function
Official Title
Hepatic Carcinoma in Poor Liver Function: Safety and Efficacy of Irreversible Electroporation (IRE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (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 investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded.
Detailed Description
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NanoKnife LEDC System
Arm Type
Experimental
Arm Description
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 any treatment
Intervention Type
Device
Intervention Name(s)
NanoKnife LEDC System
Intervention Description
90 pulses of 70 microseconds each in duration will be administered per electrode pair
Primary Outcome Measure Information:
Title
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
Time Frame
1 day post treatment to 14 days post treatment
Secondary Outcome Measure Information:
Title
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
Time Frame
30 days (+/- 3 days) post treatment
Other Pre-specified Outcome Measures:
Title
Progress Free Survival (PFS)
Time Frame
2 years post treatment
Title
Over Survival (OS)
Time Frame
5 years post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria, 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 B or ≤12， Eastern Cooperative Oncology Group (ECOG) score of 0-1, American Society of Anaesthesiologists (ASA) score ≤ 3, 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: eligible for surgical treatment or transplantation for HCC, Hepatic carcinoma 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
zhi l Niu
Organizational Affiliation
FUDA Cancer Hospital
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

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Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function

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