跳至主要内容
临床试验/NCT06361576
NCT06361576已完成不适用

Patients With Upper Gastrointestinal Adenocarcinoma Enrolled in a Patient Support Program to Receive Nivolumab in the Metastatic Setting: Real-World Data From Canada

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2023年9月5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
700
试验地点
1
主要终点
Particpant sociodemographics

研究概览

简要总结

The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.

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

入选标准

  • Enrolled in the Bristol-Myers Squibb GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma Patient Support Program (GEORgiA PsP) in Canada
  • Have consented to the use of their de-identified data generated from information collected during the course of the GEORgiA PsP

排除标准

  • Aged <18 years
  • HER2 positive status
  • Untreated brain metastases

研究组 & 干预措施

Participants enrolled and treated with nivolumab in the metastatic setting

干预措施: Nivolumab (Drug)

结局指标

主要结局

Particpant sociodemographics

时间窗: Baseline

Participant comorbidities

时间窗: Baseline

Participant tumour location

时间窗: Baseline

Participant treatment history

时间窗: Baseline

Participant Eastern Cooperative Oncology Group (ECOG) score

时间窗: Baseline

Participant HER2 status

时间窗: Baseline

次要结局

  • Participant adverse events (AEs)(Up to 75 weeks)
  • Management of participant adverse events (AEs)(Up to 75 weeks)
  • Initial nivolumab dosage prescribed to participants(Index date)
  • Number of nivolumab treatments received by participants(Up to 75 weeks)
  • Planned combination chemotherapy treatment(Index date)
  • Nivolumab treatment initiation date(Index date)
  • Nivolumab dosage modification(Up to 75 weeks)
  • Participant treatment duration(Up to 75 weeks)
  • Reason for participant discharge(Up to 75 weeks)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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