NCT06499298已完成不适用
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年12月3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
- 64
- 试验地点
- 1
- 主要终点
- Participant disease-free survival (DFS)
研究概览
简要总结
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/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 or older at the index date
- •All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis.
- •Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.
排除标准
- •Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment.
- •From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment
研究组 & 干预措施
Participants receiving adjuvant nivolumab
干预措施: Nivolumab (Drug)
结局指标
主要结局
Participant disease-free survival (DFS)
时间窗: Up to 1 year
次要结局
- Date of tumor initial diagnosis(Baseline)
- Date of nivolumab treatment completion/discontinuation(Up to 1 year)
- Time to next treatment (TTNT)(Up to 1 year)
- Nivolumab treatment regimen(Up to 1 year)
- Eastern Cooperative Oncology Group (ECOG) performance status(Baseline and up to 1 year)
- Participant outcomes after nivolumab treatment(Baseline and up to 1 year)
- Participant medical history(Baseline and up to 1 year)
- Indication for nivolumab treatment(Day 1)
- Nivolumab treatment duration(Up to 1 year)
- Time from surgery to nivolumab initiation(Day 1)
- Participant socio-demographics(Baseline and up to 1 year)
- Resected tumor margins status(Baseline)
- Participant cancer treatment history(Baseline)
- Participant concomitant treatment(s)(Baseline and up to 1 year)
- Participant systemic treatment(s)(Up to 1 year)
- Subsequent treatment after nivolumab discontinuation(Up to 1 year)
- Tumor location at initial diagnosis(Baseline)
- Tumor histology at initial diagnosis(Baseline)
- Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation(Day 1)
- Pathological tumor status(Baseline and up to 1 year)
- Pathological lymph-node status(Baseline and up to 1 year)
- Participant biomarkers (if available)(Baseline and up to 1 year)
- Reasons for treatment discontinuation/cessation(Up to 1 year)
- Nivolumab treatment modifications in relation to the management of adverse events (AE)(Up to 1 year)
- Participant distant metastasis-free survival (DMFS) rates(Up to 1 year)
- Participant distant metastasis-free survival (DMFS)(Up to 1 year)
研究者
研究点 (1)
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