The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced hepatocellular carcinoma (HCC) who have no standard of care options can affect patients survival. The main questions it aims to answer are:
* will the TheraBionic P1 device affect overall survival in advance HCC * the long term safety and tolerability of the TheraBionic P1 device * assessment of how the disease responded to the TheraBionic P1 device
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.
Patients with evaluable disease
Patients must be ≥ 22 years old and must be able to understand and sign an informed consent.
Patients with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints
Patients taking any other investigational drugs
Patients with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of the device
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 discontinued to prior to treatment on study. Patients must agree to abstain from using calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels for the duration of treatment on study.
Barbara Ann Karmanos Cancer Institute
Lead sponsor
THERABIONIC INC.
Collaborator