Menu
Recruiting NCT07118202

TheraBionic P1 Device in Subjects With Advanced Hepatocellular Carcinoma

No phase Interventional Hepatocellular Carcinoma Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TheraBionic P1.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma Recurrent. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device 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

Primary outcome measures

  • Overall Survival [Time frame: From start of treatment until death, up to 24 months]
Secondary outcome measures (9)
  • PROMIS Measures of Pain Interference [Time frame: From Start of Treatment to the end of treatment up to 12 months]
  • Patient-reported outcomes (PRO) [Time frame: From Start of Treatment to the end of treatment up to 12 months]
  • PROMIS Measures of Pain Intensity [Time frame: From Start of Treatment to the end of treatment up to 12 months]
  • ECOG Performance Status [Time frame: From Start of Treatment to the end of treatment up to 12 months]
  • Disease Control Rate [Time frame: From enrollment up to 6 months]
  • Duration of overall response [Time frame: From start of treatment up to 24 months]
  • Time to Progression (TTP) [Time frame: Start of treatment to death from any cause up to 24 months]
  • Progression-free survival (PFS) [Time frame: 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 [Time frame: From Start of Treatment to the end of treatment up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗