NCT04506138进行中（未招募）1 期
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Major Pathologic Response (MPR)
研究概览
简要总结
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histological diagnosis of thoracic Esophageal squamous cell carcinoma
- •ECOG performance status 0-1
- •Age 18-75 years
- •Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
- •Life expectancy more than 6 months
- •Use of an effective contraceptive for adults to prevent pregnancy
排除标准
- •Not suitable for surgery
- •Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
- •Prior esophageal, gastric, or gastro-esophageal junction surgery
- •Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
- •Pregnant or lactating women
研究组 & 干预措施
Camrelizumab plus Chemotherapy
Experimental
干预措施: Camrelizumab (Drug)
Camrelizumab plus Chemotherapy
Experimental
干预措施: Paclitaxel for Injection (Albumin Bound) (Drug)
Camrelizumab plus Chemotherapy
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
Major Pathologic Response (MPR)
时间窗: 12 weeks
Pathologic complete remission (PCR)
时间窗: 12 weeks
次要结局
- Overall Survival (OS)(5 years)
- Event Free Survival（EFS）(5 years)
研究者
Chenqixun
Director of Thoracic Surgery Department
Zhejiang Cancer Hospital
研究点 (1)
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