NCT06504615进行中（未招募）不适用
A French, Prospective, Observational, Multicenter Study of Patients Treated With Nivolumab Plus Chemotherapy as First Line Treatment in Advanced or Metastatic Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma or Gastric Adenocarcinoma [METAGIO]
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2024年12月10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
- 进行中（未招募）
- 发起方
- 入组人数
- 208
- 试验地点
- 4
- 主要终点
- Overall survival (OS)
研究概览
简要总结
A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Cohorts 1 & 2
- •Adult participants (at least 18 years of age at time of treatment decision)
- •Participants treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy (according to the French current marketing authorization) for the treatment of Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and prior to study participation.
- •Participants who provided oral informed consent to participate in the study
- •Cohort 1 only • Diagnosis of untreated HER2 negative advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma or EAC whose tumor express PD-L1 with a CPS ≥5
- •Cohort 2 only
- •Diagnosis of untreated unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression (TPS) ≥1%
排除标准
- •Cohorts 1 & 2
- •Participants with a primary diagnosis of a cancer other than advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC, within the past 5 years.
- •Participants currently enrolled in an interventional clinical trial for his/her advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma, EAC or ESCC.
- •Pregnant women
- •Participants under guardianship
研究组 & 干预措施
Cohort 2
Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma
干预措施: nivolumab + chemotherapy (Drug)
Cohort 1
Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma
干预措施: nivolumab + chemotherapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
次要结局
- Chemotherapy treatment regime(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Cause of death (where available)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Time to next Treatment (TTNT)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Disease progression(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Progression-free survival (PFS)(Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Time to failure of strategy (TFS)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Treatment Free Interval (TFI)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Time to treatment discontinuation (TTD)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Reason for treatment discontinuation(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Overall tumor response (ORR)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Response rate(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Participant socio-demographics(Baseline)
- Participant treatment history(Baseline)
- Second progression-free survival (PFS2)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Subsequent non-systemic treatment received post first-line treatment(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Subsequent systemic treatment received post first-line treatment(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Subsequent systemic treatment effectiveness(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Duration of response (DOR)(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Participant clinical characteristics(Baseline)
- Nivolumab treatment regime(Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36)
- Participant adverse events (AEs)(Up to 3 years)
研究者
研究点 (4)
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