NCT07062484尚未招募不适用
A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年7月1日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a retrospective real-world study. In this study, we plan to collect the clinical data of lung metastatic nasopharyngeal carcinoma patients who received PD-1 inhibitors and chemotherapy combined with or without radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of at least 18 years;
- •Karnofsky Performance Status (KPS) ≥60;
- •histologically confirmed nasopharyngeal squamous carcinoma;
- •metastatic disease after primary standard treatment (patients who had metastatic diseases over six months after treatment);
- •at least 1 measurable metastatic lesions in lung or mediastinal or pleura (imaging for distant metastases with FDG-PET/CT or chest/abdomen CT with contrast);
- •adequate renal , liver and bone marrow function.
排除标准
- •previous treatment with an immune checkpoint inhibitor;
- •recurrent disease;
- •previous systemic chemotherapy for metastatic disease;
- •symptomatic central nervous system metastases;
- •a history of non-infectious pneumonitis that required glucocorticoids, or active autoimmune disease;
- •severe organ dysfunction or not suitable for chemoradiotherapy;
- •individuals that had serious kidney, heart, blood, nervous system, or liver diseases or psychiatric disorders;
- •individuals that had taken part in any other clinical trials testing other drugs within 3 months of the present study;
- •other patients whom researchers deemed unsuitable to participate in the study.
结局指标
主要结局
Objective response rate
时间窗: 3 months
次要结局
未报告次要终点
研究者
Yangkun Luo
Director
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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