CTRI/2011/10/002087Other4 期
An open-label multicentre phase IV study of trastuzumab in combination with the standard chemotherapy (as per the routine clinical practice) as first-line therapy in patients with HER2 positive metastatic gastric cancer. - NA
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult patients, greater then equal to 18 years of Age
- •Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- •HER2 positive tumor (primary tumor or metastasis
- •ECOG Performance status 0, 1 or 2
- •Life expectancy of at least 3 months
排除标准
- •Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
- •Patients with active (significant or uncontrolled) gastrointestinal bleeding
- •Residual relevant toxicity resulting from previous chemotherapy
- •Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
研究者
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