Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma (TheraBionic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534664
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Information provided by:
University of Sao Paulo

September 24, 2007
September 26, 2007
September 26, 2007
October 2005
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No Changes Posted
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Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Hepatocellular Carcinoma
Device: TheraBionic device
Daily outpatient treatment with theraBionic device
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2007
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Inclusion Criteria:

  • Advanced biopsy-proven HCC
  • Performance status ECOG 0-1
  • Patients with Child Pugh A and B cirrhosis scores
  • Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
  • Presence of one or more measurable lesion(s) according to the RECIST criteria.
  • Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study.
  • Patients on a liver transplant waiting list may be included
  • Patient must not have curative treatment options other than liver transplant
  • Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies
  • Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases.
  • At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
  • Other anti-cancer treatments are not permitted during this study
  • Patients must be more than 18 old and must be able to understand and sign an informed consent.
  • Patient must agree to be followed up according to the study protocol.
  • Patients may have either stable disease or disease progression according to the principal investigator assessment.
  • Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study

Exclusion Criteria:

  • Suspected or biopsy confirmed brain metastases
  • Patients with hepatic cirrhosis with Child-Pugh class C
  • Patients who have received a liver transplant.
  • Patients who had a surgical resection of the disease and who do not have measurable disease.
  • Pregnant women
  • Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy
  • Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University of Sao Paulo
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Principal Investigator: Frederico P Costa, MD Disciplina de Transplante e Cirurgia do Fígado
University of Sao Paulo
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP