Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- 3-year failure free survival
研究概览
简要总结
Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed squamous cancer of nasal cavity and paranasal sinuses
- •T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery
- •NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- •ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
- •creatinine clearance rate ≥ 60 ml/min (calculated by Cockcroft-Gault)
排除标准
- •older than 65 or younger than 18
- •HBsAg (+) and HBV DNA >1×10E3 copiers /mL
- •autoimmune diseases
- •interstitial lung diseases
- •had other cancers before
研究组 & 干预措施
camrelizumab group
干预措施: camrelizumab (Drug)
结局指标
主要结局
3-year failure free survival
时间窗: 3-year
time from the randomization to the first treatment failure or death
次要结局
未报告次要终点
研究者
Fei Han
professor
Sun Yat-sen University