A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 主要终点
- pCR
研究概览
简要总结
In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.
详细描述
Project title Association analysis between sleep disorders and tumor immunity in lung cancer: a prospective study Backgroundsleep disorders have been extensively studied in recent years and have been shown to be closely related to the development and prognosis of a variety of chronic diseases, including cancer. Especially in patients with lung cancer, sleep disorders may have an important impact on immune function, treatment response and patient survival. The changes of tumor immune microenvironment play an important role in the occurrence, development and response to immunotherapy of lung cancer. However, the relationship between sleep disorders and the tumor immune microenvironment of lung cancer has not been systematically explored. Therefore, the aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective for tumor immunotherapy strategies.
Aimsthe aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective on tumor immunotherapy strategies.
Primary outcome: Changes in tumor immune microenvironment: The effect of sleep disorders on tumor immune microenvironment was evaluated by immune cell infiltration analysis and immune marker expression level evaluation. Expression levels of immune checkpoint molecules: the changes of immune checkpoint molecules such as PD-1 and PD-L1 in tumor tissues of patients were detected.
Secondary outcomes:
The overall survival (OS) and progression-free survival (PFS) were analyzed. Biomarker changes: such as changes in the levels of cytokines (IL-6, TNF-α, etc.). Patient quality of life: The impact of sleep quality on patient general health was assessed using a standardized quality of life questionnaire.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.
- •Be able to understand the study and provide informed consent
排除标准
- •Coexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)
结局指标
主要结局
pCR
时间窗: From enrollment to the end of treatment at two years"
Pathological complete response (pCR)
次要结局
未报告次要终点