jRCT1031200386招募中不适用
Exploratory study for stratification marker of immune check point inhibitor in patients with advanced or recurrent gastric or esophageal cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- Multivariate discriminant models
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with pathologically or cytologically diagnosed, advanced or recurrent, gastric or esphageal cancer, who are treated with anti-PD-1/PL-L1 antibody (measurable target lesions for response evaluation are not required).
- •Patients over 20 years old with written informed consent
- •Patients with ECOG PS 0-2
排除标准
- •Patients with the past history of immunological treatments (immune checkpoint inhibitors, cancer vaccines, or immune cell therapies)
- •Patients with regular use of amino acid formulations (asintravenous or enteral nutrition) or supplements
- •Patients with presumed abnormalities of amino acid metabolism, such as liver cirrhosis, renal failure, inborn error of amino acid metabolism, pregnancy, and feeding
- •Patients enrolled in other clinical trials for pharmaceuticals or medical devices
- •Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment]
- •Patients with other inappropriate conditions for enrollment judged by the clinicians
结局指标
主要结局
Multivariate discriminant models
Models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting overall survival in patients treated with anti-PD-1/PL-L1 antibody
次要结局
- Multivariate discriminant models
研究者
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