Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathologic complete response rate
研究概览
简要总结
Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as esophageal squamous cell carcinoma
- •Initially diagnosed as thoracic esophageal cancer
- •resectable or potantially resectable
- •II-IVA according to AJCC 8th edition；
- •Adequate organ function
排除标准
- 未提供
研究组 & 干预措施
Tislelizumab arm
Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Pathologic complete response rate
时间窗: 1 day on which pathologic results is reported
Pathologic complete response rate
次要结局
- overall survival(2 years after enrollment)
- Disease free survival(2 years after surgery)
研究者
kunyu yang
Director of Department of Oncology
Wuhan Union Hospital, China