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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Frederico P Costa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Disciplina de Transplante e Cirurgia do FĂ­gado

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

THBC-HCC-01

NCT ID:

NCT00534664

Start Date:

October 2005

Completion Date:

February 2007

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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