Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Therabionic P1 -apparaat bij personen met geavanceerd hepatocellulair carcinoom (TARGET-HCC)

9 november 2026 bijgewerkt door: Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

Therabionic P1 -apparaat voor patiënten met geavanceerd hepatocellulair carcinoom (HCC) die falen voor de eerste en tweede lijntherapie

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

198

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Werving
        • University of Michigan
        • Contact:
      • Bay City, Michigan, Verenigde Staten, 48706
        • Werving
        • Karmanos Cancer Institute at McLaren Bay Region
        • Contact:
          • Telefoonnummer: 1-989-667-2370
      • Detroit, Michigan, Verenigde Staten, 48201
        • Werving
        • Karmanos Cancer Institute
        • Contact:
      • Flint, Michigan, Verenigde Staten, 48532
        • Werving
        • Karmanos Cancer Institute at McLaren Flint
        • Contact:
          • Telefoonnummer: 1-810-342-3800
      • Lansing, Michigan, Verenigde Staten, 48910
        • Werving
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Contact:
          • Telefoonnummer: 1-517-975-9500
      • Lapeer, Michigan, Verenigde Staten, 48446
        • Werving
        • Karmanos Cancer Institute at McLaren Lapeer Region
        • Contact:
          • Telefoonnummer: 810-667-4994
      • Mount Pleasant, Michigan, Verenigde Staten, 48858
        • Werving
        • Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
        • Contact:
          • Telefoonnummer: 1-989-772-6811
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • University of Texas M.D. Anderson Cancer Center
        • Contact:
          • Kim Ross
          • Telefoonnummer: 713-794-1623

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

22 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TheraBionic P1 device

Self administered Amplitude-modulated electromagnetic fields three times daily
Apparaat: TheraBionic P1

Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: From start of treatment until death, up to 24 months

Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death from any cause.

Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival
From start of treatment until death, up to 24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PROMIS Measures of Pain Interference
Tijdsspanne: From Start of Treatment to the end of treatment up to 12 months

National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference short form 4a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health). 4 items
From Start of Treatment to the end of treatment up to 12 months
Patient-reported outcomes (PRO)
Tijdsspanne: From Start of Treatment to the end of treatment up to 12 months

Patient-reported outcomes (PRO) measures will assess the trajectory of patient rated tolerability of treatment (Functional Assessment of Cancer Therapy items regarding bother of side effects, one item), patient-rated symptomatic adverse events (11 Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events item library items)
From Start of Treatment to the end of treatment up to 12 months
PROMIS Measures of Pain Intensity
Tijdsspanne: From Start of Treatment to the end of treatment up to 12 months

NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Intensity short form 1a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain intensity (poorer health). 1 item
From Start of Treatment to the end of treatment up to 12 months
ECOG Performance Status
Tijdsspanne: From Start of Treatment to the end of treatment up to 12 months

(ECOG)Eastern Cooperative Oncology Group performance status scale to measure functional status and ability to carry out activities of daily living. A system used to assess how a patient's cancer or other serious illness affects their daily living abilities. It's a 6-point scale (0-5) where lower scores indicate better function and higher scores indicate more limitations
From Start of Treatment to the end of treatment up to 12 months
Disease Control Rate
Tijdsspanne: From enrollment up to 6 months

Disease control will be defined as the percentage of patients who are alive and have documented response status of complete response (CR), partial response (PR) or stable disease (SD) at 4 months and 6 months from the date of enrollment.
From enrollment up to 6 months
Duration of overall response
Tijdsspanne: From start of treatment up to 24 months

Measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

The duration of overall complete response is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started
From start of treatment up to 24 months
Time to Progression (TTP)
Tijdsspanne: Start of treatment to death from any cause up to 24 months

Time-to-radiological progression assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of radiological assessment documenting tumor progression. Patients who initiate post-study anticancer therapy or die without documented progression will be censored at that time point.
Start of treatment to death from any cause up to 24 months
Progression-free survival (PFS)
Tijdsspanne: Start of treatment to progression of disease, last follow-up on study or death, whichever comes first up to 24 months

Progression-free survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the later of the date of documentation of radiologic tumor progression, date of last follow-up on study treatment or death, whichever comes first. Patients who initiate post-study antitumor therapy prior to radiologic progression will be censored for PFS at that date.
Start of treatment to progression of disease, last follow-up on study or death, whichever comes first up to 24 months
PROMIS Measures of Physical Function
Tijdsspanne: From Start of Treatment to the end of treatment up to 12 months

National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) measures of physical function short form 4a. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates less physical function (poorer health). 4 items
From Start of Treatment to the end of treatment up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Barbara Ann Karmanos Cancer Institute

Medewerkers

THERABIONIC INC.

Onderzoekers

  • Hoofdonderzoeker: Anthony F Shields, M.D., Wayne State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 oktober 2025

Primaire voltooiing (Geschat)

31 augustus 2028

Studie voltooiing (Geschat)

31 augustus 2028

Studieregistratiedata

Eerst ingediend

5 augustus 2025

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2025

Eerst geplaatst (Werkelijk)

12 augustus 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2024-074
  • TR79005KCI00019 (Ander subsidie-/financieringsnummer: U Can-Cer Vive)
  • AM-001 (Andere identificatie: TheraBionic)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren