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New treatment option for Hepatocellular Carcinoma Recurrent
Official title TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07118202
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patients with advanced hepatocellular carcinoma (HCC) (defined as a liver tumor not eligible for local therapies given the extent of disease or a...
- 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...
- 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...
You likely can't join if
- Patients with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and how well...
- 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...
- 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...
See the full 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 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
- Patients with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and how well it works 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...
- 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...
- Patients with a known severe (e.g., anaphylactic) allergy to nickel
The study team makes the final eligibility decision.
Where it's taking place
- Bay City, Michigan, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Lansing, Michigan, United States
- Lapeer, Michigan, United States
- Mount Pleasant, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bay City, Michigan, United States; Detroit, Michigan, United States; Flint, Michigan, United States; Lansing, Michigan, United States; Lapeer, Michigan, United States; Mount Pleasant, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.