Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Intracranial progression-free survival
研究概览
简要总结
This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age on day of signing informed consent
- •Histopathology confirmed non-small cell lung cancer
- •Asymptomatic brain metastases
- •EGFR/ALK ROS1 driver gene mutation negative
- •RECIST 1.1 based available assessment of lesions
- •Brain metastases 1-4
- •Single lesion ≤4cm
排除标准
- •Patients with contraindication of chemotherapy Pregnant or breast feeding women
研究组 & 干预措施
cohort A
Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy
干预措施: Chemotherapy + immunotherapy (Drug)
cohort B
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
干预措施: radiotherapy (Radiation)
cohort B
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total
干预措施: Chemotherapy + immunotherapy (Drug)
cohort C
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
干预措施: radiotherapy (Radiation)
cohort C
Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total
干预措施: Chemotherapy + immunotherapy (Drug)
结局指标
主要结局
Intracranial progression-free survival
时间窗: up to 2 years from enrollment
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
sPFS
时间窗: up to 2 years from enrollment
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
次要结局
- overall survival(up to 2 years from enrollment)
- number of participants with treatment-related adverse events(up to 2 years from enrollment)
- Objective Response rate(up to 2 years from enrollment)
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital