Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

Liver Cancer Clinical Trial

Official title:

Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329106
• Other study ID #: JF-20141225
• Status: Completed
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Irreversible electroporation (IRE)
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.

Locations

Country	Name	City	State
China	FUDA Cancer Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year