Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.
详细描述
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. ORR will be studied of the four PD-1 agents（nivolumab, pembrolizumab, toripalimab, sintilimab）
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lung cancer, liver cancer and other solid cancers
- •Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents
- •At least one measurable lesion
- •Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function
排除标准
- •patients treated with PD-1 agents less than 2 terms
研究组 & 干预措施
nivolumab
Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.
干预措施: Chemotherapy (Drug)
pembrolizumab
Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.
干预措施: Chemotherapy (Drug)
toripalimab
Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.
干预措施: Chemotherapy (Drug)
sintilimab
Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 year
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
次要结局
- Number of Participants Experiencing Adverse Events (AEs)(1 year)
研究者
zhangxiaochun
Director of Cancer Precision Medical Center
The Affiliated Hospital of Qingdao University