Construction of CT Radiomics Model to Assess PD-L1 Status and Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The association of CT radiomics features with PD-L1 expression of the tumor
研究概览
简要总结
Consolidation immunotherapy of immune checkpoint inhibitor (ICI) following chemoradiotherapy (CRT) is the current standard of care for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) as it improves both progression-free survival and overall survival. However, a substantial proportion of patients still experience disease recurrence despite consolidation ICI. It is important for personalized treatment to predict the efficacy of consolidation ICI. PD-L1 expression is used as a predictive biomarker for ICI response and efficacy in advanced NSCLC, but its role in patients with stage III disease is unclear. One important reason is PD-L1 testing performed on pre-CRT tissue may not reflect changes in PD-L1 expression after CRT. CT-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. The hypothesis of this study is that CT radiomics model can assess PD-L1 status after CRT and predict the efficacy of CRT combined with ICI in unresectable locally advanced NSCLC.
详细描述
This is an observational longitudinal prospective study.
CT scan is performed before radiotherapy, during radiotherapy and at the end of radiotherapy in patients with unresectable locally advanced NSCLC who undergo CRT. Radiomic features were extracted from CT images and baseline PD-L1 expression is assessed. CT-based radiomics models is developed to assess PD-L1 expression and predict the efficacy of ICI.
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
- •Histological or cytological proven non-small cell lung cancer
- •Unresectable stage III according to American Joint Committee of Cancer stage (the eighth edition)
- •18 years or older
排除标准
- •Previous thoracic radiotherapy
- •Palliative treatment
结局指标
主要结局
The association of CT radiomics features with PD-L1 expression of the tumor
时间窗: 12 weeks
To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy
次要结局
- Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI(From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, assessed up to 5 years)
- Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI(From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years)
- Association between CT radiomics model and ICI related pneumonitis(5 years)
研究者
YI PAN
Head of the Department of Radiation Oncology
Guangdong Provincial People's Hospital