Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced Non-small Cell Lung Cancer After Chemo-radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy
研究概览
简要总结
The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Non small cell lung cancer patients confirmed by pathology;
- •They were 18-80 years old;
- •The tumor could not be resected or could not tolerate surgery;
- •Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;
- •Clinical stage III (AJCC, 8th Edition, 2017);
- •After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc;
- •Patient informed consent.
排除标准
- •After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out
- •It can not cooperate with the completion of baseline mutation screening and subsequent sample detection
- •Factors judged by other researchers not suitable for further study
结局指标
主要结局
Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy
时间窗: Six months after consolidation treatment
The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process
次要结局
- PFS(Six months after consolidation treatment)
- OS(Six months after consolidation treatment)