TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

Официальное название

TheraBionic P1 Device for Patients With Advanced Hepatocellular Carcinoma (HCC) Who Fail First and Second Line Therapy

Обзор

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

Вмешательства

• Устройство 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

Первичные конечные точки

• Overall Survival [Срок оценки: From start of treatment until death, up to 24 months]

Вторичные конечные точки (9)

• PROMIS Measures of Pain Interference [Срок оценки: From Start of Treatment to the end of treatment up to 12 months]
• Patient-reported outcomes (PRO) [Срок оценки: From Start of Treatment to the end of treatment up to 12 months]
• PROMIS Measures of Pain Intensity [Срок оценки: From Start of Treatment to the end of treatment up to 12 months]
• ECOG Performance Status [Срок оценки: From Start of Treatment to the end of treatment up to 12 months]
• Disease Control Rate [Срок оценки: From enrollment up to 6 months]
• Duration of overall response [Срок оценки: From start of treatment up to 24 months]
• Time to Progression (TTP) [Срок оценки: Start of treatment to death from any cause up to 24 months]
• Progression-free survival (PFS) [Срок оценки: 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 [Срок оценки: From Start of Treatment to the end of treatment up to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Karmanos Cancer Institute at McLaren Bay Region — Bay City
• Karmanos Cancer Institute — Detroit
• Karmanos Cancer Institute at McLaren Flint — Flint
• Karmanos Cancer Institute at McLaren Greater Lansing — Lansing
• Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer
• Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center — Mount Pleasant

Идентификаторы

NCT: NCT07118202 · 2024-074 · TR79005KCI00019 · AM-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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