Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 主要终点
- overall survival (OS)
研究概览
简要总结
The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female age 18 or more
- •Pathologically proven non-small cell lung cancer
- •MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
- •Patients have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •KPS score <60
- •History of autoimmune diseases
- •With severe hepatic and renal dysfunction
- •Has a history of (non-infectious) pneumonitis that required steroids
研究组 & 干预措施
Leptomeningeal Metastasis
Durvalumab + Intrathecal chemotherapy
干预措施: Durvalumab (Drug)
Leptomeningeal Metastasis
Durvalumab + Intrathecal chemotherapy
干预措施: methotrexate (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: 36 months
OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
Neurological Progression Free Survival(NPFS)
时间窗: 36 months
NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause
The incidence of adverse reactions
时间窗: 36 months
In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks
次要结局
- Objective response rate (ORR)(36 months)
- Progression Free Survival(PFS)(36 months)
- Neurological assessment(36 months)
研究者
Hui Bu
Study Principal Investigator
Hebei Medical University