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Dispositivo P1 terabionico in soggetti con carcinoma epatocellulare avanzato (TARGET-HCC)

9 novembre 2026 aggiornato da: Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

Dispositivo P1 terabionico per pazienti con carcinoma epatocellulare avanzato (HCC) che falliscono la terapia di prima e seconda linea

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

198

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

22 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TheraBionic P1 device

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PROMIS Measures of Pain Interference
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaboratori

THERABIONIC INC.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 ottobre 2025

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

5 agosto 2025

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2025

Primo Inserito (Effettivo)

12 agosto 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2024-074
  • TR79005KCI00019 (Altro numero di sovvenzione/finanziamento: U Can-Cer Vive)
  • AM-001 (Altro identificatore: TheraBionic)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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