TheraBionic P1 Device for Advanced Liver Cancer

This study is testing a device called TheraBionic P1 in people with advanced hepatocellular carcinoma (HCC), which is a type of liver cancer. This is for patients whose cancer has come back or spread, and who have already tried at least two other treatments or can no longer receive standard treatments. The TheraBionic P1 device uses electromagnetic fields and is given three times a day for 60 minutes each time. Researchers want to see if this device can help people live longer, how safe it is over time, and how it affects the cancer. The study plans to enroll 198 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 198 participants.
What's involved
You would self-administer the TheraBionic P1 device for three 60-minute treatments per day (morning, midday, evening).
Compensation
Not stated in the trial record.
Follow-up
Your survival will be measured from the start of treatment until death, for up to 24 months.

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NCT07118202

TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

Recruiting
NAAges 22+InterventionalTreatment
Barbara Ann Karmanos Cancer Institute
~198 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:TheraBionic P1

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over From start of treatment until death, up to 24 months
Hepatocellular Carcinoma Recurrent

NCT07118202

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Bay Region

    Bay City, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

    Mount Pleasant, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Flint

    Flint, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Lapeer Region

    Lapeer, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Anthony F Shields, M.D. · PRINCIPAL_INVESTIGATOR · Wayne State University

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Eligibility criteria

Inclusion

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

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
  • Overall SurvivalFrom start of treatment until death, up to 24 months

    Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death from any cause. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival