Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 716
- 试验地点
- 1
- 主要终点
- Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
研究概览
简要总结
Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily.
In the clinic, patients often have some complicated condition. This study aims to perform retrospective medical chart review of mCRC patients who received regorafenib treatment in two medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice setting.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mCRC patients who received at least one dose of regorafenib treatment
排除标准
- •<=20 y/o
- •Patients who did not receive regorafenib treatment will be excluded from the analysis
- •Patients with incomplete medical records that are deemed ineligible for analysis by investigator
结局指标
主要结局
Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
时间窗: through study completion, estimated 2 years
months
Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response
时间窗: through study completion, estimated 2 years
percentage
Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)
时间窗: through study completion, estimated 2 years
months
Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)
时间窗: through study completion, estimated 2 years
months
次要结局
- Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)(through study completion, estimated 2 years)
- Safety of regorafenib use in routine clinical practice setting, assessed by initial dose(through study completion, estimated 2 years)
- Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles(through study completion, estimated 2 years)
- Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)(through study completion, estimated 2 years)
- Eligibility of subsequent therapies and the outcome, assessed by treatment duration(through study completion, estimated 2 years)
- Eligibility of subsequent therapies and the outcome, assessed by PFS(through study completion, estimated 2 years)