Evaluation of Efficacy and Toxicity of Nivolumab Monotherapy for Advanced Non-small Cell Lung Cancer After First-line Treatment Failure Based on Second-generation Sequencing and Liquid Chip Platform
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PD-1 expression levels
研究概览
简要总结
In order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. The second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。
详细描述
In order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. The second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study.
- •PS > 2, lung cancer in the elderly (less than 65 years old).
- •subjects' characteristics and target disease characteristics Histologically or cytologically diagnosed as NSCLC (SQ or NSQ) and with stage IIIB/IV tumors (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, Version 8) or multimodal therapy (radiotherapy, surgical resection) Subjects who relapsed or developed disease after radical chemoradiotherapy for locally advanced diseases.
- •Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatmen
排除标准
- •Women with a positive pregnancy test at enrollment or prior to administration of study medication
- •Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
- •Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
- •Participants with carcinomatous meningitis Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
PD-1 expression levels
时间窗: before drugs thearpy
The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
tumor mutation burden
时间窗: before drugs thearpy
Detection of the average number of mutations per megabyte in tumor tissues by NGS
Serum cytokine levels
时间窗: before drugs thearpy
Detect the expression level of cytokines in serum
PD-L1 expression levels
时间窗: before drugs thearpy
The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry
Objective Response Rate (ORR) by irRC and RECIST 1.1
时间窗: 6 months
次要结局
未报告次要终点
研究者
ShiYue Li
Director，Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease