TheraBionic Amplitude-Modulated Radiofrequency Therapy for the Treatment of Recurrent Advanced Hepatocellular Carcinoma

Inclusion Criteria

• Patients with advanced hepatocellular carcinoma (HCC) (defined as a liver tumor not eligible for local therapies given the extent of disease or a livor tumor that recurred after local therapy)
• Patients who have failed at least two lines of therapy* or who are no longer eligible for any line of standard therapy or who are intolerant to at least two lines of therapy * Two lines of therapy include two different treatments, for example treatment with radioembolization and then a second line of treatment with durvalumab/tremelimumab. A line of therapy may also include external beam or ablation of the liver lesion
• Female patients of childbearing potential and their partners and male patients must agree to use adequate contraception during the period of study treatment
• Patients with a life expectancy of at least 3 months

Exclusion Criteria

• Oral mucosa is not intact (i.e., case of mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, canker sores or gingivostomatitis, herpangina, aphthae)
• Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels, e.g., amlodipine, nifedipine, ethosuximide, ascorbic acid (vitamin C), etc. unless their medical treatment is modified to prior to enrollment exclude calcium channel blockers for the duration of treatment on study
• Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device