TheraBionic P1 device for advanced liver cancer
TheraBionic P1 Device for Patients With Advanced Hepatocellular Carcinoma (HCC) Who Fail First and Second Line Therapy
This will test whether the TheraBionic P1 device can help people with advanced hepatocellular carcinoma who have no standard treatment options live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Barbara Ann Karmanos Cancer Institute Academic / other |
| Locations | 6 sites (Bay City, Michigan and 5 other locations) |
| Trial ID | NCT07118202 on ClinicalTrials.gov |
What this trial studies
In this interventional study, patients with advanced or recurrent hepatocellular carcinoma who have exhausted or are intolerant to standard therapies receive the TheraBionic P1 device and are followed over time. The trial measures overall survival as the primary outcome and also tracks long-term safety, tolerability, and tumor response. Eligible participants must have evaluable disease, be at least 22 years old, and have a life expectancy of at least three months. Treatments and follow-up are conducted at Karmanos Cancer Institute sites in Michigan.
Who should consider this trial
Good fit: Adults (≥22 years) with advanced or recurrent hepatocellular carcinoma, evaluable disease, and who have failed or are intolerant to at least two lines of standard therapy are the intended participants.
Not a fit: Patients who remain eligible for effective standard HCC treatments, who have active secondary malignancies, or who are receiving other investigational drugs are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could extend overall survival and offer a new treatment option for patients with advanced HCC who have no standard therapies left.
How similar studies have performed: This device-based approach is relatively novel for advanced HCC and there are limited published data demonstrating clear clinical benefit to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bay City, Michigan and 5 other locations
- Karmanos Cancer Institute at McLaren Bay Region — Bay City, Michigan, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Karmanos Cancer Institute at McLaren Flint — Flint, Michigan, United States (Recruiting)
- Karmanos Cancer Institute at McLaren Greater Lansing — Lansing, Michigan, United States (Recruiting)
- Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer, Michigan, United States (Recruiting)
- Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center — Mount Pleasant, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Anthony F Shields, M.D. — Wayne State University
- Study coordinator: Anthony F Shields, M.D.
- Email: shieldsa@karmanos.org
- Phone: 313-576-8735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.