Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan (SERENADE-T)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Safety of the DC bead TACE
研究概览
简要总结
To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular carcinoma in Taiwan.
详细描述
To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular carcinoma in Taiwan.
This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC bead TACE in hepatocellular carcinoma (HCC) in Taiwan
Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7.
All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY, USA). Demographic and baseline lab data are presented by using descriptive statistics Student's t-test. Survival analysis will includes all patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.
- •Patient received DC bead TACE.
排除标准
- •Patients with current any other cancer except non-melanomatous skin cancer.
- •Infiltrative HCC
- •Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no matter it is cTACE or DC bead TACE)
- •Patients received DC bead TACE and simultaneously received other therapy, such as radiotherapy, sorafenib etc.
- •Presence of collateral vessel pathways potentially endangering normal territories during embolization.
- •Presence of arteries supplying the lesion not large enough to accept DC Bead® microspheres.
结局指标
主要结局
Safety of the DC bead TACE
时间窗: One year.
Safety of the DC bead TACE is evaluated based on the incidence of Grade 3 and Grade 4 toxicities up to 8 weeks following the procedure according to National Cancer Institute's Common Terminology Criteria for adverse events (CTCAE Version 4.03).
次要结局
- Tumor response(One year.)