NCT02520453Unknown2 期
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status
- •The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation)
- •Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0
- •Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation
排除标准
- •Other PD-1 or PD-L1 inhibitors history
- •Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
- •Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- •Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
研究组 & 干预措施
Durvalumab
Experimental
Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
干预措施: Durvalumab (Drug)
Placebo
Placebo Comparator
Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 1 year
次要结局
未报告次要终点
研究者
Jong-Mu Sun
Assistant Professor
Samsung Medical Center
研究点 (1)
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