NCT07638709尚未招募不适用
Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:
- Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?
- What medical problems do participants have when receiving these treatments at different times?
- How does the timing of treatments affect the body's immune system?
Researchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.
Participants already receiving radiation and immunotherapy as part of their regular medical care will:
- Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.
- Give a small blood sample during their routine blood draws.
- Have standard magnetic resonance imaging (MRI) scans of their brain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years; no gender restriction;
- •Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;
- •Scheduled to receive radiotherapy combined with a PD-1/PD-L1 inhibitor, in accordance with real-world clinical treatment plans;
- •Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;
- •ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;
- •Voluntarily signs the informed consent form and agrees to cooperate with blood/imaging data collection and follow-up procedures.
排除标准
- •History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;
- •Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);
- •Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;
- •Pregnant or lactating women;
- •Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.
研究者
Rongrong Zhou
Department of Oncology
Xiangya Hospital of Central South University
研究点 (1)
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