Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma-A Retrospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The difference of overall survival in patients receiving different doses of regorafenib
研究概览
简要总结
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma
详细描述
To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with Hepatocellular Carcinoma. This retrospective, observational study included clinicopathological and follow-up data of patients with Hepatocellular Carcinoma who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a pathologically proven Hepatocellular Carcinoma
- •Must have been treated with regorafenib
- •Regorafenib must be used after two lines of standard antitumor therapy
排除标准
- •Application is less than one course of treatment with regorafenib
- •First - or second-line treatment with regorafenib
- •Patients with multiple primary cancers
结局指标
主要结局
The difference of overall survival in patients receiving different doses of regorafenib
时间窗: 2021.11-2021.12
In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.
The difference in overall survival between the two groups calculated by Kaplan-Meier
时间窗: 2021.7-2021.12
Survival differences between the monotherapy and combination groups
Regorafenib in combination with other drugs
时间窗: 2021.7-2021.10
In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.
次要结局
- Survival differences among the patients with different clinical phenotypes and genotypes(2021.7-2021.10)
研究者
Shujun Yang
Director
Henan Cancer Hospital