Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
详细描述
This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.
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
- •Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
- •Adult patients >=18 years of age
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- •At least have one measurable disease(according to RECIST)
- •Adequate bone marrow,renal and liver function
排除标准
- •Previous chemotherapy for advanced/metastatic disease
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
研究组 & 干预措施
albumin-bounded paclitaxel plus S-1
arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression
干预措施: albumin-bounded paclitaxel (Drug)
albumin-bounded paclitaxel plus S-1
arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression
干预措施: S-1 (Drug)
结局指标
主要结局
response rate
时间窗: 12 weeks
次要结局
- overall survival(1 year)
- number of adverse event(1 year)
- progression free survival(1 year)
研究者
Lin Yang
professor
Chinese Academy of Medical Sciences