2024-513635-24-00招募中3 期
Nivolumab during active surveillance after neoadjuvant chemoradiation for esophageal cancer: SANO-3 study
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)6 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Disease-free survival (DFS), defined as the time elapsed between inclusion and locoregional or distant disease recurrence or death, whichever comes first.
研究概览
简要总结
To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Operable patients with locoregionally advanced squamous cell- or adenocarcinoma of the esophagus or esophagogastric junction who have completed neoadjuvant chemoradiotherapy (nCRT) and have clinically complete reponse at 10-14 weeks after nCRT and are in an active surveillance protocol (SANO-2 study)
- •Written, voluntary, informed consent
排除标准
- •Patients who were treated with definitive chemoradiotherapy
- •Patients who were unable to complete all radiotherapy fractions
- •Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires
结局指标
主要结局
Disease-free survival (DFS), defined as the time elapsed between inclusion and locoregional or distant disease recurrence or death, whichever comes first.
Disease-free survival (DFS), defined as the time elapsed between inclusion and locoregional or distant disease recurrence or death, whichever comes first.
次要结局
- Proportion of patients who develop locoregional disease recurrence
- proportion of patients who develop distant metastases
- Serious adverse events and grade 3-4 adverse events from the time of their first treatment with nivolumab according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
研究者
Jessie Huizer
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (6)
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