Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.
Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.
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
- •Pathologically confirmed non-small cell lung cancer;
- •clinical stage IV (AJCC, 8th edition, 2017);
- •EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
- •age≥18 years old;
- •KPS score≥70;
- •brain metastases at diagnosis;
- •complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
- •received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
- •willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
- •informed consent of the patient.
排除标准
- •Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- •Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- •EGFR sensitive mutations were negative or EGFR mutation status was not detected.
- •Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
研究组 & 干预措施
Construction of AI models (retrospective cohort)
干预措施: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) (Drug)
Validation of AI models (prospective cohort)
干预措施: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 1 year
The time from the start of EGFR-TKI treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.
次要结局
- Intracranial Objective Response Rate (iORR)(1 year)
- Intracranial Progression-Free Survival (iPFS)(1 year)
- Overall Survival (OS)(1 year)
- Objective Response Rate (ORR)(1 year)