Randomized controlled trial of drug eluting beads based transarterial chemotherapy (TACE) with or without stereotactic body radiation therapy (SBRT) in patients with nonmetastatic unresectable hepatocellular carcinoma.(TACS-RT Study)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- To campare two years overall survival OAS and one year infield progression free survival PFS in control TACE and interventional TACE plus SBRT arm
研究概览
简要总结
This is a Phase II/III Randomized controlled trial of drug eluting beads based transarterial chemotherapy (TACE) and sorafenib with or without stereotactic body radiation therapy (SBRT) in patients with nonmetastatic unresectable hepatocellular carcinoma (TACS-RT)among 386 liver cancer patients.
The primary aim of the study is
1 To compare overall survival OAS in control TACE and intervention arm TACE plus SBRT
The secondary aims of the trial is
1 To compare cause specific survival in control and intervention.
2 To evaluate functional imaging (MRI& PET) characteristics predictive of therapeutic response and overall survival in patients with HCC.
3 To compare quality of life (QOL) in control and intervention arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Diagnosis of HCC Age more than 18yrs Barcelona Stage B Barcelona A not deemed suitable for surgery or refuse surgery.
- •Child pugh A Child pugh B score 7 out of 10 ECOG 0 to 1 Total number of measurable target lesion 2 or less than 2 Optimal predicted liver volume reserve more than 700 cc No contraindication for TACE.
- •Willing for molecular banking of tumour tissue.
排除标准
- •Exclusion Metastatic or nodal disease on staging investigations Child C Cirrhosis or previous history of liver failure Expected life span more than 6 months Active variceal bleding or orther signs of hepatic decompensation Portal venous thrombosis rendering patients unsuitable for TACE.
结局指标
主要结局
To campare two years overall survival OAS and one year infield progression free survival PFS in control TACE and interventional TACE plus SBRT arm
时间窗: two years for overall survival OAS and one year for infield progression free survival PFS respectively
次要结局
- To evaluate functional imaging MRI and PET characteristics predictive of therapeutic response and overall survival in patients with HCC(At study completion)
- To compare quality of life QOL in control and intervention arm(At study completion)
- To compare cause specific survival in control and intervention(At study completion)