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Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases ((RT-ICI))

2026年6月9日 更新者：Rongrong Zhou、Xiangya Hospital of Central South University

Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.

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:

  1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?
  2. What medical problems do participants have when receiving these treatments at different times?
  3. 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:

  1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.
  2. Give a small blood sample during their routine blood draws.
  3. Have standard magnetic resonance imaging (MRI) scans of their brain.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Rongrong Zhou, MD, PHD
  • 电话号码：+8613875898127
  • 邮箱：zhourr@csu.edu.cn

研究联系人备份

  • 姓名：Weihua Liao, MD, PHD
  • 电话号码：+8613973126486
  • 邮箱：ouwenliao@163.com

学习地点

  • 中国
    • Hunan
      • Changsha、Hunan、中国
        • Xiangya Hospital of Central South University
        • 接触：
        • 接触：
        • 副研究员：
          • Xianjing Chu, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population comprises adult patients (aged 18 years and older) histologically or cytologically diagnosed with non-small cell lung cancer (NSCLC) accompanied by brain metastases, confirmed via contrast-enhanced head MRI. These patients are seeking treatment at Xiangya Hospital and are scheduled to receive a combination of radiotherapy and PD-1/PD-L1 immune checkpoint inhibitors according to their routine, real-world clinical care plans. The cohort specifically represents a real-world NSCLC population with relatively good performance status (ECOG 0-2), intact local brain anatomy (no prior history of whole-brain radiotherapy, stereotactic radiosurgery, or brain surgery), and who are negative for actionable driver mutations or have experienced disease progression following prior targeted therapies.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Non-small cell lung cancer brain metastases

This cohort comprises adult patients (aged 18 years and older) with histologically or cytologically confirmed (NSCLC who have brain metastases confirmed by contrast-enhanced head MRI. Participants in this cohort are scheduled to receive standard-of-care radiotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors based on real-world clinical treatment plans.

Eligible participants must have an ECOG performance status of 0 to 2, an expected survival of at least 3 months, and be either driver-gene negative or have experienced disease progression following prior targeted therapies.

The cohort strictly excludes patients who have a history of WBRT, SRS for brain metastases, or brain surgery. Additionally, individuals with contraindications to MRI (or intolerance to gadolinium contrast agents), active autoimmune diseases requiring systemic treatment or long-term high-dose immunosuppressants, and pregnant or lactating women are excluded.
辐射：Brain radiotherapy

Participants in this observational study receive standard-of-care radiotherapy for brain metastases combined with PD-1/PD-L1 immune checkpoint inhibitors. The specific radiotherapy parameters (e.g., technique, target volume, and dose) and immunotherapy details (e.g., specific drug type, dosage, and administration schedule) are entirely determined by the treating physicians or multidisciplinary team (MDT) based on current clinical guidelines and real-world practice.

This study does not assign, alter, or proactively intervene in any treatment plans. What distinguishes the exposure in this study is the specific tracking and categorization of the real-world timing interval and administration sequence between radiotherapy and immunotherapy (e.g., synchronous vs. asynchronous, radiation-first vs. immunotherapy-first), aiming to evaluate how these naturally occurring temporal variations impact clinical outcomes and immune status.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Intracranial Progression-Free Survival (iPFS)
大体时间：Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).
Defined as the time from study enrollment (or completion of baseline assessment) to the first documented intracranial disease progression according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria via blinded independent central review, or death from any cause.
Up to approximately 2 years (Assessed every 2-3 months in the first year, and every 3-6 months thereafter until disease progression or death).

次要结果测量

结果测量
措施说明
大体时间
Intracranial Objective Response Rate (iORR)
大体时间：Up to approximately 2 years.
The proportion of patients achieving an intracranial Complete Response (CR) or Partial Response (PR) per RANO-BM criteria. Responses must be confirmed by consecutive imaging assessments at least 4 weeks apart.
Up to approximately 2 years.
Overall Survival (OS)
大体时间：Up to approximately 2 years.
Defined as the time from study enrollment to death from any cause.
Up to approximately 2 years.
Duration of Response (DOR)
大体时间：Up to approximately 2 years.
For patients achieving confirmed CR or PR, defined as the time from the first documented objective response to the first documented disease progression or death from any cause.
Up to approximately 2 years.
Best Overall Response (BOR)
大体时间：Up to approximately 2 years.
The best disease response recorded from the start of the study treatment until disease progression or recurrence.
Up to approximately 2 years.
Intracranial Disease Control Rate (iDCR)
大体时间：At 24 weeks
The proportion of patients who achieve CR, PR, or Stable Disease (SD) maintained for at least a specified time period (e.g., 24 weeks).
At 24 weeks
Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
大体时间：From enrollment up to 1 years after the last dose of immunotherapy.
Evaluated and tracked according to the NCI CTCAE v5.0 and specific irAE management guidelines to assess the safety of different treatment sequences.
From enrollment up to 1 years after the last dose of immunotherapy.
Incidence of Radiation Necrosis and Severe Brain Edema
大体时间：Up to approximately 2 years.
Dynamic monitoring and evaluation of the occurrence of radiation necrosis and Grade ≥3 radiation-induced brain edema, utilizing RANO-BM and related imaging criteria.
Up to approximately 2 years.

其他结果措施

结果测量
措施说明
大体时间
Parasagittal Dura (PSD) Volume
大体时间：Baseline and follow-up MRI assessments up to approximately 2 years.
Quantitative measurement of the parasagittal dura (PSD) volume derived from contrast-enhanced 7.0T MRI. PSD volume will be calculated using standardized image segmentation and volumetric analysis procedures and reported in cubic millimeters (mm³).
Baseline and follow-up MRI assessments up to approximately 2 years.
Meningeal Lymphatic Drainage Rate
大体时间：Baseline and follow-up MRI assessments up to approximately 2 years.
Quantitative assessment of meningeal lymphatic drainage efficiency measured using contrast-enhanced 7.0T MRI. Drainage rate will be calculated according to predefined imaging analysis protocols and expressed as a percentage or kinetic parameter reflecting lymphatic drainage function.
Baseline and follow-up MRI assessments up to approximately 2 years.
Meningeal Lymphatic Vessel Diameter
大体时间：Baseline and follow-up MRI assessments up to approximately 2 years.
Mean diameter of visualized meningeal lymphatic vessels measured on contrast-enhanced 7.0T MRI using standardized image analysis methods and reported in millimeters (mm).
Baseline and follow-up MRI assessments up to approximately 2 years.
Deep Cervical Lymph Node (dCLN) Inflow Rate
大体时间：Baseline and follow-up MRI assessments up to approximately 2 years.
Quantitative assessment of contrast agent inflow into deep cervical lymph nodes measured using contrast-enhanced 7.0T MRI. The inflow rate will be used as an indicator of meningeal lymphatic drainage function.
Baseline and follow-up MRI assessments up to approximately 2 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Xiangya Hospital of Central South University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月5日

初级完成 (估计的)

2029年5月31日

研究完成 (估计的)

2030年6月1日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026051108
  • ZXQ2026B05 (其他赠款/资助编号：Central South University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

IPD will not be made publicly available on open-access platforms to safeguard patient privacy. However, de-identified and aggregated datasets, or specific subsets of IPD underlying the published results, might be shared conditionally. Such data will only be provided upon reasonable request from qualified academic researchers, subject to the approval of the Institutional Review Board (IRB) of Xiangya Hospital and the execution of a formal Data Use Agreement (DUA).

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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