RECRUITING

TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

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

Conditions

Hepatocellular Carcinoma Recurrent
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Related Conditions:

Hepatocellular Carcinoma Recurrent

Study Overview

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Study Details

Study overview

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

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

TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

Condition
Hepatocellular Carcinoma Recurrent
Intervention / Treatment

-

Contacts and Locations

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Barbara Ann Karmanos Cancer Institute,

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

Study Record Dates

2027-08-31