NCT02305043已完成不适用
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study
University of Leipzig1 个研究点 分布在 1 个国家目标入组 549 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 549
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response
研究概览
简要总结
The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •histologically proven adenocarcinoma of the stomach or gastroesophageal junction
- •patient receives chemotherapy
- •signed informed consent
- •Age > 18 years
排除标准
- •Patient can not understand meaning and purpose of the study
- •patient already received a chemotherapy treatment for advanced disease.
结局指标
主要结局
Percentage of Participants With Objective Response
时间窗: 12 months
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion
次要结局
- time-to-progression(up to 24 months)
- overall survival(up to 24 months)
研究者
Florian Lordick, MD
Director University Cancer Center Leipzig
University of Leipzig
研究点 (1)
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