Recruiting

TheraBionic P1

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT07118202

Conditions

Hepatocellular Carcinoma Recurrent

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

TheraBionic P1

Study Details

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

Conditions

Hepatocellular Carcinoma Recurrent

Study ID

NCT07118202

Start date

Oct 20, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

198 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TheraBionic P1 device

Self administered Amplitude-modulated electromagnetic fields three times daily

Interventions

TheraBionic P1

Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening

Primary outcome measure

  • Overall Survival [ Time Frame: From start of treatment until death, up to 24 months ]

Central Contacts and Locations

Central contacts

Anthony F Shields, M.D.

313-576-8735shieldsa@karmanos.org

Locations

Karmanos Cancer Institute at McLaren Bay Region

Recruiting

Bay City, Michigan, United States, 48706

Contacts

1-989-667-2370

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Anthonly F Shields, M.D.

313-576-8735shieldsa@karmanos.org

Karmanos Cancer Institute at McLaren Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

1-810-342-3800

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

1-517-975-9500

Karmanos Cancer Institute at McLaren Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

810-667-4994

Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

Recruiting

Mount Pleasant, Michigan, United States, 48858

Contacts

1-989-772-6811

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2026-04-13.