TheraBionic P1 device for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.