Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1-year PFS
研究概览
简要总结
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
详细描述
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
- •No prior anti-cancer treatment.
- •No significant internal medical conditions or major organ dysfunction.
排除标准
- •Histological evidence of small cell lung cancer or other primary malignancies
- •EGFR, ALK, or ROS-1 gene mutations.
- •Active or prior autoimmune/inflammatory disorders.
- •Inability to comply with study protocol as judged by the investigator.
研究组 & 干预措施
Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy
干预措施: Carbon ion radiotherapy (Radiation)
Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy
干预措施: Chemotherapy (Drug)
Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy
干预措施: Immunotherapy (Drug)
结局指标
主要结局
1-year PFS
时间窗: 12 months
Time between enrollment and recurrence of disease or death
Incidence of Grade ≥3 Treatment-Related Adverse Events
时间窗: Occurrence or end of follow-up（3 years after enrollment), which comes first
Safety
次要结局
- OS(Occurrence or end of follow-up（3 years after enrollment）, which comes first)
研究者
Ji Yongling
PI
Zhejiang Cancer Hospital