NCT06055816招募中2 期
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of patients with grade 3 or higher adverse events (AEs).
研究概览
简要总结
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥65 years with newly pathologically confirmed NPC
- •Karnofsky performance status ≥60
- •Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition)
- •Adequate organ function
排除标准
- •Cancer history
- •Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy
- •Life-expectance within 6 months
研究组 & 干预措施
Gemcitabine Combined With Endostar and Envafolimab
Experimental
Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy.
干预措施: Endostar and Envafolimab (Drug)
结局指标
主要结局
The proportion of patients with grade 3 or higher adverse events (AEs).
时间窗: Up to 24 weeks
The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
未报告次要终点
研究者
Chen Xiaozhong
Professor
Zhejiang Cancer Hospital
研究点 (1)
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