NCT07118202 TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma
| NCT ID | NCT07118202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barbara Ann Karmanos Cancer Institute |
| Condition | Hepatocellular Carcinoma Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 198 participants in total. It began in 2025-10-20 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 evaluable disease * 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: * 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. * Patients who are breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued. * Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device for the prescribed period and frequency (three 60-minute treatments in the morning, middle of the day, and evening) * Patients with a known severe (e.g., anaphylactic) allergy to nickel
Contact & Investigator
Anthony F Shields, M.D.
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT07118202 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Hepatocellular Carcinoma Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07118202 currently recruiting?
Yes, NCT07118202 is actively recruiting participants. Contact the research team at shieldsa@karmanos.org for enrollment information.
Where is the NCT07118202 trial being conducted?
This trial is being conducted at Bay City, United States, Detroit, United States, Flint, United States, Lansing, United States and 2 additional locations.
Who is sponsoring the NCT07118202 clinical trial?
NCT07118202 is sponsored by Barbara Ann Karmanos Cancer Institute. The principal investigator is Anthony F Shields, M.D. at Wayne State University. The trial plans to enroll 198 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.