REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
研究概览
简要总结
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
详细描述
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
- Primary objective:
-
To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by,
-
Adverse events and serious adverse events (non-specific and radiation specific)
-
Changes in liver function parameters
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To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best overall response rate after SIRT
- Secondary objectives:
- To observe the efficacy of SIRT by,
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
时间窗: 6 months
Toxicity will be accessed according to CTCAE v4.03. The incidence of adverse events will be summarized and the change in baseline liver function will be assessed by paired t-test or Wilcoxon signed rank test.
次要结局
- Overall survival(1 year)
- Time-to-progression per RECIST 1.1 and mRECIST(1 year)
- Progression-free survival(1 year)
- Liver transplantation rate(1 year)
- Overall Response Rate per RECIST 1.1 and mRECIST(1 year)
- Liver resection rate(1 year)
- Time-to-liver progression per RECIST 1.1 and mRECIST(1 year)
研究者
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Principal Investigator, Dr. Rheun-Chuan Lee
Taipei Veterans General Hospital, Taiwan