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A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)


Inclusion Criteria:



- HCC 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 ≤ 3 cm in diameter,

- Child-Pugh class A,

- Eastern Cooperative Oncology Group (ECOG) score of 0,

- American Society of Anaesthesiologists (ASA) score ≤ 3,

- a prothrombin time ratio > 50%,

- platelet count > 50x109/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,

- presence of vascular invasion or extrahepatic metastases,

- received previous treatment for HCC,

- HCC 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

30 days (+/- 3 days) post treatment

Safety Issue:

Yes

Principal Investigator

Riccardo Lencioni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pisa School of Medicine

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ONC-205

NCT ID:

NCT01078415

Start Date:

February 2010

Completion Date:

October 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • HCC
  • Hepatocellular Carcinoma
  • Early Stage
  • Prospective
  • Multicenter
  • Irreversible Electroporation (IRE)
  • Electroporation
  • Low Energy Direct Current
  • LEDC
  • Nonthermal ablation
  • NTIRE (nonthermal IRE)
  • Ablation
  • Soft Tissue
  • Carcinoma
  • Carcinoma, Hepatocellular

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