NCT04526080撤回2 期
A Randomized Phase II Study Of Intrabucally Administered Electromagnetic Fields Versus Placebo as Third-line Therapy For Patients With Advanced Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Overall Survival
研究概览
简要总结
The primary goal of this study is to gather efficacy data concerning overall survival with electromagnetic field when compared to a placebo amplitude-modulated radiofrequency electromagnetic field device in subjects who have failed or are intolerant to at least two previous systemic therapies
详细描述
Primary Objective: To estimate overall survival.
Secondary Objectives
- To estimate progression-free survival.
- To evaluate safety and tolerability in this patient population.
- To evaluate the effect on levels of alpha-fetoprotein.
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
- Double (Care Provider, Investigator)
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 hepatocellular carcinoma that is locally advanced or metastatic
- •Patients must have measurable disease.
- •Failure or intolerance to prior treatments with at least two different approved or experimental systemic therapies including sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilumab, atezolizumab and bevacizumab, or any approved or experimental first line and/or second line therapy that did not include the TheraBionic device (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 10 weeks after the last systemic treatment
- •Measurable disease according to mRECIST for hepatocellular carcinoma.
- •At least one target lesion should not have previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to mRECIST for hepatocellular carcinoma.
- •Patients with Child's Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child Pugh Calculator.-Subjects with Child's Pugh score of B8-B9 may be included if they have: Albumin > 2.8 mg/l AND Total Bilirubin < 3.0mg/l, Performance status ECOG 0-
- •Patient must not have curative treatment options, including surgery or radiofrequency ablation, available as assessed by their physician.
- •Any extra-hepatic metastases, including treated CNS metastases but patients cannot have leptomeningeal disease.
- •At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
- •Other anti-cancer treatments are not permitted during this study
- •Patients must be more than 18 years old and must be able to understand and sign an informed consent.
- •Patient must agree to be followed up according to the study protocol.
排除标准
- •Known leptomeningeal disease.
- •Fibro lamellar hepatocellular carcinoma.
- •Patients with any of the following history within the 12 months prior to study drug administration: severe/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
- •Has received treatment for other carcinomas within the last three years except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or stage I breast cancer, non-invasive bladder cancer, or treated in-situ cervical 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. are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.
结局指标
主要结局
Overall Survival
时间窗: 6 months
Overall survival will be assessed on an intention to treat basis using a 2-sided log rank test to compare hazard rates between groups. Kaplan-Meier survival curves will also be generated and median survival and corresponding 95% confidence intervals will be estimated for each group.
次要结局
- Number of Adverse Events(Up to 28 days after last study treatment administration)
- Response Rates(6 months)
- Progression-Free Survival(Up to 2 years)
- Changes in Alfa-Fetoprotein Levels(6 months)
- Proportion of Patients Progression Free After 12 weeks(12 weeks, 4 months and 6 months)
研究者
研究点 (5)
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