跳至主要内容
临床试验/NCT02305043
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

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

发起方
University of Leipzig
申办方类型
Other
责任方
Principal Investigator
主要研究者

Florian Lordick, MD

Director University Cancer Center Leipzig

University of Leipzig

研究点 (1)

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