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Therabionisches P1 -Gerät bei Probanden mit fortgeschrittenem hepatozellulärem Karzinom (TARGET-HCC)

9. November 2026 aktualisiert von: Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

Therabionisches p1

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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

198

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

22 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TheraBionic P1 device

Self administered Amplitude-modulated electromagnetic fields three times daily
Gerät: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS Measures of Pain Interference
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Barbara Ann Karmanos Cancer Institute

Mitarbeiter

THERABIONIC INC.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Oktober 2025

Primärer Abschluss (Geschätzt)

31. August 2028

Studienabschluss (Geschätzt)

31. August 2028

Studienanmeldedaten

Zuerst eingereicht

5. August 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. August 2025

Zuerst gepostet (Tatsächlich)

12. August 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2024-074
  • TR79005KCI00019 (Andere Zuschuss-/Finanzierungsnummer: U Can-Cer Vive)
  • AM-001 (Andere Kennung: TheraBionic)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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