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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma

Conditions
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Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Device: TheraBionic device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TheraBionic device|Daily outpatient treatment with theraBionic device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |