TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

Barbara Ann Karmanos Cancer Institute

Status

Enrolling

Conditions

Hepatocellular Carcinoma Recurrent

Treatments

Device: TheraBionic P1

Study type

Interventional

Funder types

Other

Identifiers

NCT07118202

2024-074

Details and patient eligibility

About

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

Enrollment

198 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.
Patients with pacemakers or other implantable devices may be treated with the TheraBionic P1 device.
Patients must be ≥ 22 years old and must be able to understand and sign an informed consent.
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. (Refer to Appendix B for a comprehensive list of excluded medications)
Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.