Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT07118202
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07118202
Study Brief:
Protocol Section:
NCT07118202