A Mechanism Study to Investigate the Difference in Efficacy of Neoadjuvant PD-1 Blockade Combined With Chemotherapy in the Treatment of IIA-IIIB Stage Lung Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathological response assessment
研究概览
简要总结
To explore mechanisms of immunotherapy resistance and relation to changes in the TME before and after PD-1 blockade combined with chemotherapy
详细描述
The biobank of thoracic surgery department of Tangdu Hospital collected pre-treatment tissues from patients during endoscopy. The investigators retrospectively summarized the clinical characteristics of these patients and patients with operable locally advanced lung squamous cell carcinoma were selected and followed.
The investigators plan to employ snRNA-seq and scRNA-seq respectively to profile 20 samples of paired pre-treatment and post-treatment tumors from ten patients (discovery cohort) to create a cell atlas for analysis, and spatial transcriptomics to examine 8 samples from four patients. In discovery cohort, estimated 5 patients achieve major pathological response (MPR) and 5 patients achieve non-MPR after NICB.
After analyzing the results of discovery cohort, the investigators will collect frozen tissues and formalin-fixed, paraffin-embedded (FFPE) tissue from our biobank for bulk RNA-seq analysis or immunohistochemistry (IHC) staining as validation cohort to further investigate the predictive value and biological significance of our markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40 to 80 years;
- •had histologically confirmed LUSC with operable locally advanced stage
- •no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
- •pre-treatment tissues
排除标准
- •the presence of central nervous system metastases
- •the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment;
- •uncontrolled hypertension
- •history of or having pulmonary fibrosis or interstitial lung disease
结局指标
主要结局
Pathological response assessment
时间窗: through study completion, an average of 2 year
MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR
次要结局
未报告次要终点