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.
Single group
TheraBionic P1
DeviceAmplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening
Overall Survival
Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death from any cause. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival
PROMIS Measures of Pain Interference
National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference short form 4a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health). 4 items
Patient-reported outcomes (PRO)
Patient-reported outcomes (PRO) measures will assess the trajectory of patient rated tolerability of treatment (Functional Assessment of Cancer Therapy items regarding bother of side effects, one item), patient-rated symptomatic adverse events (11 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events item library items)
PROMIS Measures of Pain Intensity
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Intensity short form 1a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain intensity (poorer health). 1 item
ECOG Performance Status
(ECOG)Eastern Cooperative Oncology Group performance status scale to measure functional status and ability to carry out activities of daily living. A system used to assess how a patient's cancer or other serious illness affects their daily living abilities. It's a 6-point scale (0-5) where lower scores indicate better function and higher scores indicate more limitations
Click on the lead sponsor to view all of their trials.
Barbara Ann Karmanos Cancer Institute
Lead sponsor
THERABIONIC INC.
Collaborator
