jRCT1031240320招募中不适用
Exploratory study of biomarkers associated with "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (Biomarker study for YOTSUBA trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 主要终点
- Creation of a multivariate discriminant model
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
- •Biliary tract cancer patients enrolled in "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (KHBO-2201)
排除标准
- •History of immunotherapy (anti-PD-1/PD-L1 antibody therapy, anti-CTLA-4 antibody therapy, cancer vaccine therapy, immune cell therapy, etc.).
- •Regular use of amino acid preparations (intravenous nutrition, enteral component nutrition, etc.) or amino acid supplements (concomitant use of anamorelin hydrochloride is acceptable).
- •Presumed abnormalities of amino acid metabolism (cirrhosis, renal failure, congenital abnormalities of amino acid metabolism, etc.).
结局指标
主要结局
Creation of a multivariate discriminant model
Combination of plasma amino acid concentrations to predict overall survival in advanced biliary tract cancer patients treated with gemcitabine/cisplatin/S-1 combination therapy and gemcitabine/cisplatin/immune checkpoint inhibitor combination therapy.
次要结局
- Creation of a multivariate discriminant model
研究者
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