The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis：A Phase II Prospective Single Arm Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
- 主要终点
- tumor response rate
研究概览
简要总结
This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
- •Voluntarily participate in this study and sign an informed consent form
- •The presence of evaluable size and number of pulmonary metastases on chest CT
- •There are indications for lung puncture biopsy
- •General physical condition (ECOG) 0-1
- •The laboratory test meets the following standards: white blood cell count>3.5 × 109/L, absolute value of neutrophils>1.8 × 109/L, platelet count ≥ 75 × 109/L, hemoglobin ≥ 100g/L; NR ≤ 1.5, and APTT ≤ 1.5 times the upper limit of normal value or partial prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; Total bilirubin ≤ 1.25 times the upper limit of normal value; ALT and AST<5 times the upper limit of normal values; 24-hour creatinine clearance rate>50mL/min or blood creatinine<1.5 times the upper limit of normal value.
排除标准
- •Unable to tolerate or refuse further immunotherapy
- •Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
研究组 & 干预措施
experimental group
The enrolled subjects will receive SBRT treatment combined with Puterizumab.
干预措施: Stereotactic Body Radiation Therapy，SBRT (Radiation)
experimental group
The enrolled subjects will receive SBRT treatment combined with Puterizumab.
干预措施: Puterizumab (Drug)
结局指标
主要结局
tumor response rate
时间窗: From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
The tumor response rate will evaluate the local control of lung metastases，referring to the evaluation criteria for solid tumor efficacy RECIST 1.1
次要结局
- overall survival(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.)
- RTOG acute radiation injury grading(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.)
- QLQ-30 score(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.)
- Lymphocyte subpopulation analysis(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.)
- Minor Residual Lesions(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.)
- progression-free survival(From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.)