TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

NCT07118202 | Recruiting FDA Device

• 3 other identifiers: 2024-074TR79005KCI00019AM-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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

  From start of treatment until death, up to 24 months

Secondary Outcomes (9)

• PROMIS Measures of Pain Interference

  From Start of Treatment to the end of treatment up to 12 months

• Patient-reported outcomes (PRO)

  From Start of Treatment to the end of treatment up to 12 months

• PROMIS Measures of Pain Intensity

  From Start of Treatment to the end of treatment up to 12 months

• ECOG Performance Status

  From Start of Treatment to the end of treatment up to 12 months

• Disease Control Rate

  From enrollment up to 6 months

Study Arms (1)

TheraBionic P1 device

EXPERIMENTAL

Self administered Amplitude-modulated electromagnetic fields three times daily

Device: TheraBionic P1

Interventions

TheraBionic P1 DEVICE

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

TheraBionic P1 device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• THERABIONIC INC.: collaborator

Study Sites (6)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, 48706, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, 48532, United States

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, 48446, United States

RECRUITING

Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

Mount Pleasant, Michigan, 48858, United States

RECRUITING

Study Officials

• Anthony F Shields, M.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony F Shields, M.D.

CONTACT

313-576-8735; shieldsa@karmanos.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (6)