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

University of Sao Paulo1 site in 1 country40 target enrollmentOctober 2005

ConditionsAdvanced Hepatocellular Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Hepatocellular Carcinoma
Sponsor: University of Sao Paulo
Enrollment: 40
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

February 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Sao Paulo

Eligibility Criteria

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.

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