跳至主要内容
临床试验/NCT06361563
NCT06361563已完成不适用

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

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 250 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
250
试验地点
1
主要终点
Participant primary upper gastrointestinal cancer diagnosis

研究概览

简要总结

The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant 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 Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada
  • Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP

排除标准

  • Aged <18 years
  • Did not receive concurrent chemoradiotherapy prior to surgery
  • Positive margins following resection
  • No residual disease following complete resection

研究组 & 干预措施

Participants treated with adjuvant nivolumab

干预措施: Nivolumab (Drug)

结局指标

主要结局

Participant primary upper gastrointestinal cancer diagnosis

时间窗: Baseline

Participant comorbidities

时间窗: Baseline

Date of tumour resection

时间窗: Baseline

Participant Eastern Cooperative Oncology Group (ECOG) score

时间窗: Baseline

Participant tumour location

时间窗: Baseline

Participant sociodemographics

时间窗: Baseline

Participant histology results

时间窗: Baseline

次要结局

  • Number of nivolumab treatments received(Up to 484 days)
  • Participant adverse events (AEs)(Up to 484 days)
  • Initial nivolumab dosage prescribed to participants(Index date)
  • Nivolumab treatment duration(Up to 484 days)
  • Nivolumab dosage modification(Up to 484 days)
  • Reason for participant discharge(Up to 484 days)
  • Management of participant adverse events (AEs)(Up to 484 days)

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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