RECRUITING

TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

TheraBionic P1 Device for Patients With Advanced Hepatocellular Carcinoma (HCC) Who Fail First and Second Line Therapy

Quick Facts

Study Start:2025-08-31

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07118202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 pacemakers or other implantable devices may be treated with the TheraBionic P1 device. * 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	* Oral mucosa is not intact (i.e., case of mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, canker sores or gingivostomatitis, herpangina, aphthae). * 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 modified to prior to enrollment exclude calcium channel blockers for the duration of treatment on study. (Refer to Appendix B for a comprehensive list of excluded medications) * Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.

Inclusion Criteria

Exclusion 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 pacemakers or other implantable devices may be treated with the TheraBionic P1 device.
* 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

* Oral mucosa is not intact (i.e., case of mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, canker sores or gingivostomatitis, herpangina, aphthae).
* 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 modified to prior to enrollment exclude calcium channel blockers for the duration of treatment on study. (Refer to Appendix B for a comprehensive list of excluded medications)
* Patients that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.

Contacts and Locations

Study Contact

Anthony F Shields, M.D.

CONTACT

313-576-8735

shieldsa@karmanos.org

Principal Investigator

Anthony F Shields, M.D.

PRINCIPAL_INVESTIGATOR

Wayne State University

Study Locations (Sites)

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Collaborators and Investigators

Sponsor: Barbara Ann Karmanos Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-31

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-08-31

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Hepatocellular Carcinoma Recurrent