NCT07118202招募中不适用
TheraBionic P1 Device for Patients With Advanced Hepatocellular Carcinoma (HCC) Who Fail First and Second Line Therapy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 7
- 主要终点
- Overall Survival
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TheraBionic P1 device
Experimental
Self administered Amplitude-modulated electromagnetic fields three times daily
干预措施: TheraBionic P1 (Device)
结局指标
主要结局
Overall Survival
时间窗: 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
次要结局
- PROMIS Measures of Pain Interference(From Start of Treatment to the end of treatment up to 12 months)
- ECOG Performance Status(From Start of Treatment to the end of treatment up to 12 months)
- Patient-reported outcomes (PRO)(From Start of Treatment to the end of treatment up to 12 months)
- PROMIS Measures of Pain Intensity(From Start of Treatment to the end of treatment up to 12 months)
- Disease Control Rate(From enrollment up to 6 months)
- Time to Progression (TTP)(Start of treatment to death from any cause up to 24 months)
- Progression-free survival (PFS)(Start of treatment to progression of disease, last follow-up on study or death, whichever comes first up to 24 months)
- Duration of overall response(From start of treatment up to 24 months)
- PROMIS Measures of Physical Function(From Start of Treatment to the end of treatment up to 12 months)
研究者
Anthony F. Shields, MD PhD
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (7)
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