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Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy

2026年6月22日更新者：Jie Wang、Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer

This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

600

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：Jie Wang, MD,PhD
电话号码：8610-87788029
邮箱：zlhuxi@163.com

研究联系人备份

姓名：Jie Zhao, MD
电话号码：17801204737
邮箱：zhaojie_12@163.com

学习地点

中国
- - Beijing、中国
    - 招聘中
    - Cancer Hospital Chinese Academy of Medical Sciences
    - 接触：
      
      Jie Zhao, MD
      
      电话号码：17801204737
      
      邮箱：zhaojie_12@163.com
    - 接触：
      
      Jie Wang, MD, PhD
      
      电话号码：8610-87788029
      
      邮箱：zlhuxi@163.com

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

This study population consists of patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitor (ICI)-based therapy (monotherapy or combination therapy) as first-line or later-line treatment. Participants are derived from real-world data across multiple centers in China, including Cancer Hospital, Chinese Academy of Medical Sciences, and its affiliated hospitals, as well as from completed phase III clinical trials (Choice-01, Rationale-307, Rationale-304). A total of approximately 600 patients will be included and classified into two groups based on overall survival: long-term survival group (LTS, OS > 5 years) and short-term survival group (STS, OS < 1 year).

描述

Inclusion Criteria:

Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).
Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences [Shanxi Cancer Hospital]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).
Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.
Patients with complete clinical information and available follow-up data.

Exclusion Criteria:

Patients whose systemic therapy did not include an immunotherapy regimen.
Patients lost to follow-up.

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

团体/队列数

队列和干预

团体/队列
Long-term survival (LTS) group patients with overall survival of more than 5 years after initial immunotherapy
Short-term survival (STS) group patients with overall survival of less than 1 year after initial immunotherapy

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
OS 大体时间：From date of first ICI-based therapy initiation to death due to any cause, or censored at the date of last known follow-up, assessed up to 5 years (retrospectively collected from medical records).	Overall Survival	From date of first ICI-based therapy initiation to death due to any cause, or censored at the date of last known follow-up, assessed up to 5 years (retrospectively collected from medical records).

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

调查人员

首席研究员：Jie Wang, MD, PhD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 (实际的)

2026年5月1日

初级完成 (估计的)

2030年5月1日

研究完成 (估计的)

2030年5月1日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)