NCT03695510已完成2 期
Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, A Single-Arm, Phase II Study (ALPHA Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The primary objectives of the trial is to examine the toxicities and efficacies of afatinib and pembrolizumab for recurrent and/or metastatic head and neck squamous cell carcinoma.
详细描述
It is a single arm, phase II, single center, prospective, open label clinical trial.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study arm
Experimental
afatinib + pembrolizumab
干预措施: Afatinib Oral Tablet (Drug)
Study arm
Experimental
afatinib + pembrolizumab
干预措施: Pembrolizumab Injection (Drug)
结局指标
主要结局
Objective response rate
时间窗: 2 years
The objective response rate will be measured by RECIST 1.1.
次要结局
- Overall survival(2 years)
- Toxicities(2 years)
研究者
研究点 (1)
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