Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with esophageal squamous cell cancer;
- •staged with cT1N+M0/cT2-3N0-3M0;
- •experienced no cancer-related treatment;
- •ECOG 0-1;
- •Expected survival more than 6 months;
- •aimed at neoadjuvant therapy for surger;
- •have adquate organ function.
排除标准
- •diagnosed with other types of cancer during last five years;
- •have a tendency to bleed;
- •accepted any type of cancer-related therapy.
结局指标
主要结局
pCR
时间窗: perioperative
pathological complete response
次要结局
未报告次要终点
研究者
Xiangbo Wan
Vice-president of the First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Zhengzhou University