Clinical trial NCT02329106: 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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
timeFrame: up to 7 days
Secondary outcomes:
measure: 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)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: FUDA Cancer Hospital
state: Guangdong
Study officials:
affiliation: President
name: Lizhi Niu, M.D.,PHD.
role: STUDY_CHAIR
References: