NCT03906058已完成2 期
Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年4月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- disease control rate
研究概览
简要总结
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proved nasopharyngeal carcinoma;
- •stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- •18 years or older; without other malignancy;
- •proper functioning of the major organs.
排除标准
- •allergic to anlotinib;
- •female within gestation period or lactation;
- •patients received drug of other clinical trial within 4 weeks.
研究组 & 干预措施
Anlotinib
Experimental
干预措施: Anlotinib (Drug)
结局指标
主要结局
disease control rate
时间窗: 30 months
disease control rate
次要结局
- duration of response(30 months)
- overall survival(30 months)
- progression-free survival(30 months)
- overall response rate(30 months)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University
研究点 (1)
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