NCT06611137招募中2 期
SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年9月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
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
- •Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th
- •age 18-70
- •PS score 0-1
- •normal functions to tolerate chemotherapy, immunotherapy and radiotherapy
排除标准
- •Patients with a combination of other malignant tumours
- •Individuals with contraindications to immunotherapy
结局指标
主要结局
objective response rate
时间窗: two weeks after the last course of neoadjuvant chemotherapy
complete and partial response rate
次要结局
未报告次要终点
研究者
Fang-Yun Xie
professor
Sun Yat-sen University
研究点 (1)
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