NCT06394427尚未招募不适用
Influence of Neoadjuvant Chemoimmunotherapy on Treatment Response in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- major pathological remission
研究概览
简要总结
to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world
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
- •Confirmed as primary lung cancer through cytology or histological examination;
- •ECOG score of 0 or 1; ③ 18 years old or above;
- •Received imaging examination, with a preliminary clinical staging of stage III;
- •Received genetic testing and tested negative for EGFR mutations, ALK or ROS-1 fusion; ⑥ Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ Receive surgical treatment after completion of neoadjuvant therapy; ⑧ The postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available.
排除标准
- •Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;
- •Accept other neoadjuvant treatments; ④ Patients participating in any clinical trial.
结局指标
主要结局
major pathological remission
时间窗: one month
proportion of patients with no more than 10% residual viable tumor cells; patients who showed no viable tumor in the lung primary setting but lymph nodes show viable metastatic carcinoma were also classified as MPR
survival time
时间窗: 5 years
time since diagnosed with NSCLC
pathological complete remission
时间窗: one month
proportion of patients without residual viable tumor cell on evaluation of resected lung cancer specimens including all sampled regional lymph nodes
次要结局
未报告次要终点
研究者
Pengfei Li
Research Assistant
West China Hospital
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