Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
- 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
- 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
- Extra hepatic metastases do not constitute an exclusion criterion, except for active
- 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
- 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
- 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
- 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