Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078415
• Other study ID #: ONC-205
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: November 7, 2016
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Device:
• Ablation with the NanoKnife Low Energy Direct Current (LEDC) System
90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Locations

Country	Name	City	State
France	Hopital Beaujon	Paris
France	L'institut de cancerologie Gustave Roussy	Villejuif	Ile-de-France
Germany	Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin	Magdeburg
Italy	Istituto Nazionale Tumori - Fondazione Pascale	Naples
Italy	University of Pisa School of Medicine	Pisa	Tuscany
Spain	Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

References & Publications (10)

Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodés J; EASL Panel of Experts on HCC.. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. — View Citation

Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases.. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. — View Citation

Jonas S, Bechstein WO, Steinmüller T, Herrmann M, Radke C, Berg T, Settmacher U, Neuhaus P. Vascular invasion and histopathologic grading determine outcome after liver transplantation for hepatocellular carcinoma in cirrhosis. Hepatology. 2001 May;33(5):1080-6. — View Citation

Lencioni R, Cioni D, Crocetti L, Franchini C, Pina CD, Lera J, Bartolozzi C. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology. 2005 Mar;234(3):961-7. — View Citation

Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. Review. — View Citation

Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials.. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Review. — View Citation

Llovet JM, Fuster J, Bruix J. Intention-to-treat analysis of surgical treatment for early hepatocellular carcinoma: resection versus transplantation. Hepatology. 1999 Dec;30(6):1434-40. — View Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. — View Citation

Yao FY, Bass NM, Nikolai B, Davern TJ, Kerlan R, Wu V, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: analysis of survival according to the intention-to-treat principle and dropout from the waiting list. Liver Transpl. 2002 Oct;8(10):873-83. — View Citation

Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.		30 days (+/- 3 days) post treatment	Yes
Secondary	Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.		Immediately post treatment to 2 years post treatment	Yes