Exploring the Mechanism of Cerebrospinal Fluid Immune Microenvironment in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Lung Cancer With Brain Metastases Treated With Iruplinalib: an Interventional Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
研究概览
简要总结
This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
- •Confirmed diagnosis of brain metastases or suspected brain metastases
- •Iruplinalib is proposed for treatment
- •Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
- •Adequate organ and marrow function
排除标准
- •Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
- •The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
- •The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
- •Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
研究组 & 干预措施
Iruplinalib
The treatment will be administrated for 16 weeks, after which the treatment regimen was determined by the investigator.
干预措施: Iruplinalib (Drug)
结局指标
主要结局
Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
时间窗: 28 days
Cerebrospinal fluid levels of natural killer (NK) cells,CD3+ T cells,CD4+ T cells,CD8+ T cells,tumour necrosis factor alpha(TNF-α), interleukin-6(IL-6), interferon-gamma(IFN-γ), high C-reactive protein(hs-CRP),immunoglobulin A(IgA),immunoglobulin E(IgE),immunoglobulin G(IgG),immunoglobulin M(IgM),intercellular adhesion molecule 1(ICAM-1) and vascular cell adhesion molecule 1(VCAM-1).
次要结局
- Iruplinalib concentration in cerebrospinal fluid(Day 28)
- Objective response rate(16 weeks)
- Disease control rate(16 weeks)
- Intracranial objective response rate(16 weeks)
- Intracranial disease control rate(16 weeks)