New device offers hope for liver cancer patients out of options
NCT ID NCT07118202
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called TheraBionic P1 in people with advanced liver cancer who have already tried at least two other treatments or cannot take standard therapy. The goal is to see if the device can help them live longer and improve their quality of life. About 198 adults will use the device at home, and researchers will track survival, side effects, and how the cancer responds.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Exclusion Criteria: * Patients with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy 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 treatment is discontinued to prior to treatment on study. Patients must agree to abstain from using calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels for the duration of treatment on study. * 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, middle of the day, and evening) * Patients with a known severe (e.g., anaphylactic) allergy to nickel
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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Karmanos Cancer Institute at McLaren Bay Region
RECRUITINGBay City, Michigan, 48706, United States
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Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
RECRUITINGMount Pleasant, Michigan, 48858, United States
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Karmanos Cancer Institute at McLaren Flint
RECRUITINGFlint, Michigan, 48532, United States
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Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITINGLansing, Michigan, 48910, United States
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Karmanos Cancer Institute at McLaren Lapeer Region
RECRUITINGLapeer, Michigan, 48446, United States
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