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Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

Primary Purpose

Hepatic Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NanoKnife
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
  • Tumor from gallbladder is <0.5 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 ≤ 7 cm in diameter,
  • Child-Pugh class A,B
  • 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

  • 中国

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NanoKnife IRE System

Control

Arm Description

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

Outcomes

Primary 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.

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02332551
Brief Title
Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder
Official Title
A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder
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
August 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 close to the gallbladder, also Progress Free Survival (PFS) 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), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. 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 necrosis 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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoKnife IRE 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
Intervention Type
Device
Intervention Name(s)
NanoKnife
Other Intervention Name(s)
IRE
Intervention Description
Irreversible electroporation (IRE) is a new, minima-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 the gallbladder .
Primary 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
Secondary Outcome Measure Information:
Title
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
Time Frame
Immediately post treatment to 2 years post treatment
Other Pre-specified Outcome Measures:
Title
Progress free survival(PFS)
Time Frame
24months

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: Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria, Tumor from gallbladder is <0.5 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 ≤ 7 cm in diameter, Child-Pugh class A,B 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
Lizhi l Niu, PHD
Organizational Affiliation
FUDA Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
中国
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

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Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

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