Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Local tumor control (efficacy fo SBRT)
研究概览
简要总结
Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE
详细描述
The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.
In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open labled
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Eastern cooperative oncology group(ECOG) score 0 to 2
- •Primary HCC
- •HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
- •Child-Turgottei-Pugh A or B
- •Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
- •No evidence of radiologically definable major vascular invasion or extrahepatic disease
- •Previously incomplete TACE with radiologically defined residual disease after first TACE
- •Informed consent
排除标准
- •Prior TACE to the target lesion
- •Contraindication to receiving radiotherapy or TACE
- •Decompensated liver cirrhosis
- •Extrahepatic mets
- •Pregnancy
- •Patients with other cancers
研究组 & 干预措施
SBRT (Stereotatic body radiotherapy)
Treatment of SBRT in HCC patients who have incomplete response after first TACE
干预措施: SBRT (Radiation)
TACE (Transarterial chemoembolization)
Treatment of repeated TACE in HCC patients who have incomplete response after first TACE
结局指标
主要结局
Local tumor control (efficacy fo SBRT)
时间窗: 1 year
To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.
次要结局
- overall survival(2 year)
- progression free-survival(2 year)
- Radiation induced liver disease (RILD)(1 year)