Clinical trial NCT01078415: Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)
Official title: A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
Hepatocellular Carcinoma
Early Stage
Prospective
Multicenter
Irreversible Electroporation (IRE)
Electroporation
Low Energy Direct Current
LEDC
Nonthermal ablation
NTIRE (nonthermal IRE)
Ablation
Soft Tissue
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
timeFrame: 30 days (+/- 3 days) post treatment
Secondary outcomes:
measure: Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
timeFrame: Immediately post treatment to 2 years post treatment
Other outcomes:
Locations:
city: Villejuif
country: France
facility: L'institut de cancerologie Gustave Roussy
state: Ile-de-France
city: Paris
country: France
facility: Hopital Beaujon
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin
city: Pisa
country: Italy
facility: University of Pisa School of Medicine
state: Tuscany
city: Naples
country: Italy
facility: Istituto Nazionale Tumori - Fondazione Pascale
city: Barcelona
country: Spain
facility: Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: University of Pisa School of Medicine
name: Riccardo Lencioni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona
name: Jordi Bruix, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
citation: Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
citation: Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes 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. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.
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. doi: 10.1002/hep.20933. No abstract available.
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. Epub 2008 May 13.
citation: Jonas S, Bechstein WO, Steinmuller 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. doi: 10.1053/jhep.2001.23561.
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. doi: 10.1053/jhep.2001.24563.
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. doi: 10.1148/radiol.2343040350. Epub 2005 Jan 21.
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. doi: 10.1002/hep.510300629.
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. doi: 10.1053/jlts.2002.34923.