Apatinib Plus S-1 for Advanced Gastric Cancer Refractory to Oxaliplatin Plus Capecitabine Combination Therapy: A Single-arm, Phase-2, Home-based Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- median progression-free survival(mPFS)
研究概览
简要总结
This is a single-arm, interventional study aimed to observe the efficacy and safety of Apatinib combined with S-1 for patients with advanced gastric cancer refractory to oxaliplatin plus capecitabine combination 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 —（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
Apatinib Mesylate tablets combined with S-1 capsules
single arm trial: apatinib 500 mg once daily, across entire cycle and S-1 60 mg twice daily, on the first 14 days of a 21-day cycle. Medication was continued until the disease progression, withdrawal requirement, or intolerable adverse events
干预措施: Apatinib Mesylate tablets combined with S-1 capsules (Drug)
结局指标
主要结局
median progression-free survival(mPFS)
时间窗: 2 years
The median duration of time between when a patient with oncological disease receives treatment and when the disease progresses or death due to any cause occurs.
median overall survival(mOS）
时间窗: 2 years
The median time from treatment to the last follow-up or death.
次要结局
- objective response rate(ORR)(2 years)
- disease control rate(DCR) DCR(2 years)
研究者
Zhongtao Zhang
Professor
Beijing Friendship Hospital