NCT04793139尚未招募不适用
Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Prospective, Observational, Multicenter Real-World Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- AE,Grade 3-5
研究概览
简要总结
This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.
详细描述
Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Sign the informed consent and volunteer to participate in the study;
- •Non-small cell lung cancer confirmed by histological/cytopathological tests;
- •The investigators determined that patients should receive camrelizumab alone or in combination.
排除标准
- •Patients who are also receiving other immunomedications or therapies;
- •Patients participating in other interventional studies;
- •Patients complicated with other malignant tumors;
- •Women who have been confirmed to be pregnant or lactating;
- •The Investigator considers the patient unsuitable for participation in any other condition of the study.
结局指标
主要结局
AE,Grade 3-5
时间窗: From April 1, 2021 to Septeember 30, 2024
Safety of the general population:Serious Adverse Events (AE)，Grade 3-5.
次要结局
- PFS(From April 1, 2021 to December 30, 2022)
- OS(From April 1, 2021 to December 30, 2022)
- MPR(From April 1, 2021 to December 30, 2024)
- pCR(From April 1, 2021 to December 30, 2024)
- R0 resection rate(From April 1, 2021 to December 30, 2022)
- ORR(From April 1, 2021 to December 30, 2022)
研究者
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