Exosome Detection for Predicting Treatment Efficacy in Advanced NSCLC With Malignant Pleural Effusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
The goal of this observational study is to investigate the predictive value of exosome characteristics in patients with advanced non-small cell lung cancer (NSCLC) and malignant pleural effusion (MPE). The main question it aims to answer is:
Can the long RNA profile of exosomes derived from plasma and malignant pleural effusion predict treatment response in patients with advanced NSCLC and MPE? Participants who are scheduled to receive standard systemic therapy (including immunotherapy, chemotherapy, or targeted therapy) as part of their regular medical care will be enrolled. Researchers will collect paired samples of peripheral blood and malignant pleural effusion at baseline and key time points during treatment to analyze the exosomal long RNA profiles and correlate them with treatment efficacy and survival outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •- Confirmed advanced-NSCLC Aged 18-75 years. ECOG performance status of 0-
- •At least one measurable lesion as per RECIST 1.
- •Adequate bone marrow, liver, and renal function. Willing and able to provide written informed consent.
排除标准
- •- Mixed small cell lung cancer histology. Symptomatic or untreated brain metastases. Uncontrolled cardiovascular diseases or severe comorbidities. Active hepatitis B/C or HIV infection.
结局指标
主要结局
objective response rate (ORR)
时间窗: From date of enrollment until the first documented progression or death from any cause, assessed up to 24 months.
Primary Objective: To investigate the association between baseline exLR expression profiles in plasma and malignant pleural effusion and the objective response rate (ORR) as assessed by RECIST 1.1 in patients with advanced NSCLC and MPE receiving systemic therapy.
次要结局
未报告次要终点