A Korean Multicenter Prospective Observational Study on Efficacy of 90Y for Hepatocellular Carcinoma-early Stage
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The aim of the current study is to analyze treatment outcomes (best target lesion response, overall survival, time to target lesion progression, time to overall progression, and treatment-related adverse event) using prospectively collected clinical and imaging data in patients with BCLC 0 or A HCCs treated with TheraSphere® in four large-volume hospitals from Korea. The results will pave the way for expanding 90Y-TARE indication and refining reimbursement guidelines, and provide baseline data for possible subsequent future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A. Patients receiving TARE using TheraSphere® B. Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) C. Tumor involvement < 50% of total liver volume based on dynamic CT or MRI D. Age > or = 18 E. ECOG performance status 0 F. AST/ALT < or = 5 times the upper limits of normal G. A life expectancy > 3 months H. Non-pregnant with an acceptable contraception in premenopausal women I. Ability to provide written informed consent and to comply with all study conditions
排除标准
- •A. Contraindications to angiography and selective catheterization B. Known anaphylaxis to iodinated contrast C. Expected lung dose > 30Gy per a session D. Unable to avoid non-target 90Y flow into the extrahepatic organs except the lungs E. Decompensated liver cirrhosis (Child-Pugh score > 7) F. Active uncontrolled infection G. Pregnancy H. Current or history (< or = 5 years) of malignancies in the other organs I. History of liver transplantation J. Any vascular invasion
结局指标
主要结局
Overall survival
时间窗: From enrollment to the end of treatment at 3 years
Overall survival
best target lesion response
时间窗: "From enrollment to the end of treatment at 3 years
best target lesion response
次要结局
- Time to target lesion progression(From enrollment to the end of treatment at 3 years)
- Time to overall progression(From enrollment to the end of treatment at 3 years)
- Treatment-related adverse events rates(From enrollment to the end of treatment at 3 years)
研究者
Yoon Jun Kim
Professor
Seoul National University Hospital