NCT06452329已完成不适用
Retrospective Evaluation of Nivolumab in First-Line Unresectable Advanced or Metastatic Gastric Cancer (GC) and Gastroesophageal Junction Cancer (GEJC): A Non-interventional Observational Study in China
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
The purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) in China
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participants aged ≥ 18 years at date of first administration of nivolumab
- •Confirmed diagnosis of unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (histologically or cytologically)
- •Participants newly received nivolumab as first-line (1L) treatment between 15 June 2018 and 30 June 2023
- •Participants with at least one tumor assessment after index date except for death or discontinuation due to Adverse Events
排除标准
- •Participants with primary malignancies other than unresectable advanced or metastatic GC/GEJC
- •Participants who participate in an interventional clinical trial in or before 1L nivolumab treatment for advanced/metastatic GC/GEJC
- •Participants with known HER2 status positive
- •Participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete
研究组 & 干预措施
Participants who received first-line nivolumab therapy for advanced GC/GEJC
干预措施: Nivolumab (Drug)
结局指标
主要结局
Time to progression (TTP)
时间窗: Up to 68 months
次要结局
- Participant baseline clinical characteristics(Baseline)
- Objective response rate (ORR)(Up to 68 months)
- Duration of response (DOR)(Up to 68 months)
- Participant socio-demographics(Baseline)
- Participant treatment patterns(Up to 68 months)
研究者
研究点 (2)
Loading locations...
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