Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

NCT02329106 | Completed DMC

• 1 other identifier: JF-20141225
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 7 days

Secondary Outcomes (1)

• 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)

  1 year

Study Arms (2)

NanoKnife LEDC System

EXPERIMENTAL

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.

Device: Irreversible electroporation (IRE)

Control

NO INTERVENTION

The patients without treatment

Interventions

Irreversible electroporation (IRE) DEVICE

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.

Also known as: NanoKnife

NanoKnife LEDC System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

FUDA Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Lizhi Niu, M.D.,PHD.

  President

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2019-05

Locations

CN (1)