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

Cancer Categories

Gastrointestinal (GI)

Karmanos Trial ID

2024-074

NCT ID

NCT07118202

Age Group

Adult

Scope

National

Phase

Phase IV

Principal Investigator

Anthony
Shields, M.D., Ph.D.
Oncology - Medical View Profile

Objective:

Primary Objective:

Assess the overall survival in patients receiving TheraBionic treatment

Secondary Objectives:

Assess trajectory of treatment tolerability, symptomatic adverse events, pain intensity, pain interference, and physical function from baseline throughout treatment
Estimate overall response rate and disease control rate
Estimate duration of overall response and duration of overall complete response
Estimate duration of stable disease, time to radiological progression and progression-free survival

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Eligibility

Eligibility

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 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

Exclusion Criteria:

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)

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices