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

NCT01078415 | Completed

• 1 other identifier: ONC-205
• Study Type: interventional
• Target: 26
• Locations: 4 countries
• Sites: 6

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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

  Immediately post treatment to 2 years post treatment

Interventions

Ablation with the NanoKnife Low Energy Direct Current (LEDC) System DEVICE

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Also known as: System also known as:, * Low Energy Direct Current (LEDC) System, * HVP01 Electroporation System, * NanoKnife LEDC System, * NanoKnife IRE System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (6)

Hopital Beaujon

Paris, 92110, France

Location

L'institut de cancerologie Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

Location

Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin

Magdeburg, D-39120, Germany

Location

University of Pisa School of Medicine

Pisa, Tuscany, 56124, Italy

Location

Istituto Nazionale Tumori - Fondazione Pascale

Naples, 80131, Italy

Location

Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (10)

• Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

  PMID: 14667750 BACKGROUND

• 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.

  PMID: 15761078 BACKGROUND

• 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.

  PMID: 11592607 BACKGROUND

• 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.

  PMID: 16250051 BACKGROUND

• 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.

  PMID: 18477802 BACKGROUND

• 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.

  PMID: 11343235 BACKGROUND

• 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.

  PMID: 11391528 BACKGROUND

• 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.

  PMID: 15665226 BACKGROUND

• 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.

  PMID: 10573522 BACKGROUND

• 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.

  PMID: 12360427 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Riccardo Lencioni, MD

  University of Pisa School of Medicine

  PRINCIPAL INVESTIGATOR

• Jordi Bruix, MD

  Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

DE (1); IT (2); ES (1); FR (2)