Actively Recruiting
TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2026-04-13
198
Participants Needed
6
Research Sites
149 weeks
Total Duration
On this page
Sponsors
B
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
T
THERABIONIC INC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced hepatocellular carcinoma (HCC) defined as a liver tumor not eligible for local therapies or recurrence after local therapy
- Patients who have failed at least two lines of therapy or are no longer eligible or intolerant to standard therapies
- Patients with evaluable disease
- Patients aged 22 years or older who can understand and sign informed consent
- Female patients of childbearing potential and their partners and male patients agree to use adequate contraception during treatment
- Patients with a life expectancy of at least 3 months
You will not qualify if you...
- Patients with known active secondary malignancy unless unlikely to interfere with study endpoints
- Patients taking any other investigational drugs
- Patients with active oral mucosal inflammation, ulceration, or other pathology interfering with device use
- Patients receiving calcium channel blockers or agents blocking L-type or T-type voltage gated calcium channels unless discontinued before treatment and agree to abstain during study
- Patients who are breastfeeding unless breastfeeding is discontinued
- Patients unwilling or unable to follow the study protocol or use the device as prescribed (three 60-minute treatments daily)
- Patients with a known severe allergy to nickel
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, United States, 48706
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
3
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
4
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
5
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
6
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
Mount Pleasant, Michigan, United States, 48858
Actively Recruiting
Research Team
A
Anthony F Shields, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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