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
赞助:
Guangzhou Institute of Respiratory Disease
合作者:
信息的提供 (责任方):
ShiYue Li，Guangzhou Institute of Respiratory Disease
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | May 1, 2018 | ||
| 预计主要完成日期 | January 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
PD-L1 expression levels[ Time Frame: before drugs thearpy ] The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry PD-1 expression levels[ Time Frame: before drugs thearpy ] The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry tumor mutation burden[ Time Frame: before drugs thearpy ] Detection of the average number of mutations per megabyte in tumor tissues by NGS Serum cytokine levels[ Time Frame: before drugs thearpy ] Detect the expression level of cytokines in serum Objective Response Rate (ORR) by irRC and RECIST 1.1[ Time Frame: 6 months ] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[ Time Frame: 6 months ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | 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 | ||
| 正式标题 ICMJE | 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 | ||
| 简要概况 | 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。 |
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| 详细说明 | 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。 | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
80 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 31, 2019 | ||
| 预计主要完成日期 | January 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - 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 | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ShiYue Li，Guangzhou Institute of Respiratory Disease | ||
| 研究赞助商 ICMJE | Guangzhou Institute of Respiratory Disease | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Guangzhou Institute of Respiratory Disease | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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