The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With Hepatic Arterial Infusion Chemotherapy of FOLFOX for HCC: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
This is a multicenter，retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Eligible patients diagnosed with high-risk HCC initiating the study treatment of interest between 28 October 2020 and 31 June 2025 will be included in this study. Secondary data from medical records of approximately 10 sites across China will be utilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FOLFOX+TA
FOLOFOX-HAIC plus Atezolizumab and Bevacizumab
干预措施: Atezolizumab & Bevacizumab (Drug)
FOLFOX+TA
FOLOFOX-HAIC plus Atezolizumab and Bevacizumab
干预措施: FOLFOX-HAIC (Procedure)
结局指标
主要结局
overall survival (OS)
时间窗: 6 months
defined as time from index date to death from any cause.
次要结局
- Real-world progression-free survival (rwPFS)(6 months)
- Time to discontinuation (TTD)(6 months)
- Time to next treatment (TTNT)(6 months)
- Serum alpha-fetoprotein (AFP) reduction(6 months)
- Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction(6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University