2024-512136-30-00招募中4 期
An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion
Orszagos Onkologiai Intezet2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2024年6月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- 1. Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2. Local relapse free survival 3. Progression free survival 4. Overall survival.
研究概览
简要总结
An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- • Not recurrent glioblastoma multiforme patients (either after opus or with no opus) before radiotherapy and temozolomide therapy. Recurrent patients who have already undergone other therapeutic intervention (surgery, radiotherapy and temozolomide therapy) and due to the recurrence of the disease, based on clinical experience, it is justified to start bevacizumab therapy. Known relapse patients who are already receiving bevacizumab therapy.
排除标准
- • Unwillingness to sign the written Informed Consent Form. History of psychiatric diseases and treatment. Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. Participation in another clinical trial within 3 months prior to this study. Known drug or chronic alcohol abuse, drug addiction. Malignant disease other than GBM. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study. Evidence of an uncooperative attitude. Vulnerable subject.
结局指标
主要结局
1. Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2. Local relapse free survival 3. Progression free survival 4. Overall survival.
1. Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2. Local relapse free survival 3. Progression free survival 4. Overall survival.
次要结局
- Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.
研究者
Orszagos Onkologiai Intezet
Scientific
Orszagos Onkologiai Intezet
研究点 (2)
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