NCT05334719已完成不适用
A Non-interventional Observational Study of Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced / Recurrent Gastric Cancer
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.
详细描述
The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or recurrent gastric cancer
- •Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31,
- •For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable
- •Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study.
排除标准
- •Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled)
- •Confirmed to be positive for HER2
- •Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects
- •Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site.
- •Judged by the investigators to be inappropriate for enrollment in this study
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to approximately 4 years
Objective response rate (ORR)
时间窗: Up to approximately 4 years
Incidence of all immune-related adverse events (irAE) according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: Up to approximately 4 years
Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation
时间窗: Up to approximately 4 years
次要结局
- Overall survival (OS)(Up to approximately 4 years)
- Duration of response (DOR)(Up to approximately 4 years)
- Duration of treatment (DOT)(Up to approximately 4 years)
- Time to next treatment (TNT)(Up to approximately 4 years)
- Number of participants who have received subsequent therapy(Up to approximately 4 years)
- Incidence of Adverse Events (AEs)(Up to approximately 4 years)
研究者
研究点 (2)
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