Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Complete pathologic response
研究概览
简要总结
The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
- •clinically staged as T1-4N0-2M0
- •having undergo neoadjuvant chemoimmunotherapy
- •the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
- •having undergo surgery with lymph nodes (LNs) dissection
- •having postoperative pathology reports with evaluation of primary tumor and LNs response
- •having accessible pretreatment and preoperative radiology examinations imaging or reports
排除标准
- •using PD-1/L1 inhibitors in the phase of clinical trials
- •the agents of neoadjuvant therapy including angiogenesis inhibitors
- •having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery
研究组 & 干预措施
Neoadjuvant immunochemotherapy NSCLC group
NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.
干预措施: Immunotherapy (Drug)
结局指标
主要结局
Complete pathologic response
时间窗: through study completion, an average of 3 months
Tumors with 0% viable tumor cells
次要结局
- Major pathologic response(through study completion, an average of 3 months)
- Complete pathologic response in lymph nodes(through study completion, an average of 3 months)
研究者
Hao Long
Professor
Sun Yat-sen University