A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for the treatment of advanced solid tumors.
详细描述
The study is a real-world study and the case records of patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to analyze the effectivity and safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced solid tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Pathologically or cytologically confirmed advanced solid tumors;
- •Received anti-PD-1/PD-L1 antibody therapy.
排除标准
- •No specific exclusion criteria in this real world study.
研究组 & 干预措施
Anti-PD-1/PD-L1 antibodies
Patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy
干预措施: Anti-PD-1/PD-L1 antibodies (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 6 months
PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.
次要结局
- Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with advanced solid tumors receiving anti-PD-1/PD-L1 antibody therapy.(up to 4 weeks after the last dose)
- Objective Response Rate (ORR)(6 months)
- Disease Control Rate (DCR)(6 months)
- Overall survival (OS)(up to 12 months)
研究者
Xiao Zhao
Principal Investigator
Chinese PLA General Hospital