NCT03334591Unknown2 期
Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progress free survival(PFS)
研究概览
简要总结
The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.
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 (Outcomes Assessor)
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
- •Male and female patients,age≥18years
- •Confirmed by Pathology or histology of Gastric cancer
- •Patients who failed first-line chemotherapy
- •The ECOG physical status score:0 to 2
- •Expected survival ≥3months
- •Patients should be voluntary to the trail and provide with signed informed consent.
- •The researchers believe patients can benefit from the study.
排除标准
- •Pregnant or lactating women
- •Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
- •Patients with apatinib contraindications
- •Patients of doctors considered unsuitable for the trail
研究组 & 干预措施
Apatinib 5 days' continuous use and 2 days' off
Experimental
Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer
干预措施: Apatinib (Drug)
Apatinib 500mg continuous use
Active Comparator
Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer
干预措施: Apatinib (Drug)
结局指标
主要结局
progress free survival(PFS)
时间窗: 1 year
From data of randomization until the date of first dccumentde progression or date of death from any cause
次要结局
- disease control rate (DCR)(1year)
- Objective tumor response rate(ORR)(1year)
- overall survival (os)(1year)
- Quality of life score(1 year)
- adverse events(1 year)
研究者
研究点 (1)
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