Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Retrospective, Observational, Multicenter Real-World Study
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- pCR
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
- Retrospective
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 old;
- •Histopathological diagnosed confirmed non-small cell lung cancer;
- •Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020;
- •Traceable cases.
排除标准
- •Patients who have received other immunotherapy at the same time;
- •Patients who were participating in other intervention studies;
- •Patients with other malignant tumors;
- •The researcher believes that the patient is not suitable to participate in this study with any other conditions .
研究组 & 干预措施
Camrelizumab-treated advanced NSCLC
Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
pCR
时间窗: From August 1, 2019 to June 31, 2021
Neoadjuvant therapy population: pathological complete response rate (pCR).
R0 resection rate.
时间窗: From August 1, 2019 to June 31, 2021
Neoadjuvant therapy population: R0 resection rate.
ORR
时间窗: From August 1, 2019 to June 31, 2021
Advanced non-small cell lung cancer: objective response rate (ORR).
6-month PFS%
时间窗: From August 1, 2019 to June 31, 2021
Advanced non-small cell lung cancer: 6-month progression-free survival rate (PFS%).
次要结局
- MPR(From August 1, 2019 to June 31, 2021)
- operative rate(From August 1, 2019 to June 31, 2021)
- perioperative mortality(From August 1, 2019 to June 31, 2021)
- incidence of major postoperative complications(From August 1, 2019 to June 31, 2021)
- iORR(From August 1, 2019 to June 31, 2021)
- iPFS(From August 1, 2019 to June 31, 2021)
- AE(From August 1, 2019 to June 31, 2021)
- SAE(From August 1, 2019 to June 31, 2021)