A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 14
- 主要终点
- Overall Survival
研究概览
简要总结
The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
详细描述
Primary Objectives
To compare the overall survival between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare the patient-reported disease-related symptoms between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Secondary Objectives
To compare progression-free survival between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven HCC that is locally advanced or metastatic OR
- •Patients without biopsy confirmation are also eligible if they meet one of the following criteria:
- •Radiologic diagnosis of HCC as per the AASLD guidelines OR
- •Liver cirrhosis AND a liver mass that shows arterial phase hyperenhancement on triphasic computed tomography (CT) or MRI, AND either:
- •Is ≥ 20 mm with either non-peripheral portal washout or an enhancing capsule OR
- •Is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule
- •For Child-Pugh A participants: treatment failure (defined as documented radiological progression) and/or intolerance to at least two prior treatments with approved or experimental systemic therapies including atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilimumab, pembrolizumab or any other approved or experimental first line and/or second line therapy.
- •Child-Pugh B participants are not required to have received any prior treatment.
- •Measurable disease according to RECIST v 1.
- •At least one target lesion that has not previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, transarterial chemoembolization (TACE), hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to RECIST v 1.1 and mRECIST for HCC.
- •Patients with Child-Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child-Pugh Calculator. Subjects with Child-Pugh score of B8-B9 may be included if they have:
- •Albumin ≥ 2.8 mg/l AND
- •Total Bilirubin ≤ 3.0mg/l.
- •ECOG performance status of 0-
- •At least 2 weeks must have elapsed since administration of any anticancer treatment prior to initiation of protocol therapy.
- •Patients must be greater than or equal to 18 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.
排除标准
- •Known leptomeningeal disease. (Previously treated, asymptomatic central nervous system (CNS) metastases are eligible).
- •Fibrolamellar HCC or combined hepatocellular-cholangiocarcinoma (cHCC-CC).
- •Prior treatment with the TheraBionic Device.
- •Patients with any of the following within the 12 months prior to registration: uncontrolled/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
- •Pregnant or breastfeeding women.
- •Patients with another active malignancy within the past one year except for treated cervical cancer in situ, treated in situ carcinoma of the bladder or treated non-melanoma carcinoma of the skin, low-risk prostate cancer not requiring active treatment, treated T1/T2 glottic cancer, treated stage 0 or stage I breast cancer not requiring adjuvant therapy or treated non-invasive bladder cancer.
- •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 modified to exclude calcium channel blockers prior to enrollment.
- •Patients with curative treatment options available, including surgery or radiofrequency ablation, as assessed by their physician.
- •Patients receiving other anticancer treatments.
- •Patients that do not agree to be followed according to the study protocol.
结局指标
主要结局
Overall Survival
时间窗: Baseline to 6 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. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival.
Quality of Life Survey
时间窗: Baseline to 6 months
Patient-reported hepatobiliary-specific disease-related symptoms will be assessed by the 18-item FACT-Hepatobiliary (Hep) subscale every cycle for the first 6 cycles then every other cycle thereafter, at the end of treatment, and at every 3 months during follow-up.
次要结局
- Proportion of Participants That Are Progression Free(At 12 weeks, 4 months and 6 months and up to 2 years)
- Incidences of Adverse Events - CTCAE version 5.0(Up to 28 days after study treatment administration or until death)
- Progression-Free Survival(Up to 2 years)
- Changes in Alfa-Fetoprotein Levels(6 months)
- Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5(At baseline and every 6 weeks up to 6 months)
- Proportion of Patients With Disease Control(At 4 months and 6 months and up to 2 years)
- Frequency of Adverse Events - PRO-CTCAE(At baseline and every 8 weeks up to 6 months)