Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 1
- 主要终点
- To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
研究概览
简要总结
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
详细描述
not mandatory
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point
- •Age 18 years or older at the time of aRCC diagnosis
- •Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line
排除标准
- 未提供
结局指标
主要结局
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
时间窗: during treatment period
description of overall response
To estimate time to treatment discontinuation
时间窗: during treatment period
calculation of duration of treatment
To describe the percentage of patients with documentation of dose modifications
时间窗: during treatment period
describe dose modifications
To describe the percentage of patients with usage of concomitant high-dose corticosteroid
时间窗: during treatment period
descriptive assessment
To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy
时间窗: during study period
calculation of overall survival time
To estimate PFS
时间窗: during treatment period
calculation of progression free survival
To describe type of immune related adverse events and adverse events related to axitinib
时间窗: during treatment period
describe type of immune related adverse events and adverse events related to axitinib
次要结局
未报告次要终点