NCT06712017Enrolling By Invitation不适用
A Descriptive, Retrospective, Single-Arm Cohort Study on the Use of Selective Internal Radiation Therapy (SIRT) with Yttrium-90 Microspheres for Unresectable Primary Hepatocellular Carcinoma (HCC) in the Chinese Population
GrandPharma (China) Co., Ltd.6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- best hepatic ORR measured by mRECIST criteria
研究概览
简要总结
Yttrium-90 (y90) Microsphere Injection Solution was approved by the NMPA in 2022. Currently, there is a lack of summary of real-world data in China. Therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of HCC patients treated with y90 in China, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of HCC patients in China.
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
- •age ≥ 18 years old;
- •confirmed diagnosis of HCC
- •treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment
排除标准
- •no formal exclusion criteria in a real-world study
结局指标
主要结局
best hepatic ORR measured by mRECIST criteria
时间窗: 6 months following y90 therapy
次要结局
- ORR measured by mRECIST criteria(6 months following y90 therapy)
- OS(From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months)
- TTP(From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months)
- PFS(From date of first Y90 therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(6 months following y90 therapy)
研究者
研究点 (6)
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