Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The incidence and duration of onset of clinical symptoms.
研究概览
简要总结
To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.
详细描述
Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Head MRI confirmed RI lesions. Sign the informed consent.
排除标准
- •With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
研究组 & 干预措施
HNC patients with radiation-induced brain injury.
Bevacizumab 2.5mg/kg， q2w，4 cycles.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
The incidence and duration of onset of clinical symptoms.
时间窗: Change form baseline to evaluation at 1 year.
The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.
次要结局
- change of RI volume.(Change form baseline to evaluation at 1 year.)
- change of cognitive function.(Change form baseline to evaluation at 1 year.)
- overall survival(Change form baseline to evaluation at 1 year.)
- change of quality of life.(Change form baseline to evaluation at 1 year.)