Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
详细描述
This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
This randomized controlled trial screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.
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
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
- 否
入选标准
- •Solitary HCC >3-<5 cm
- •Absence of extra-hepatic metastases
- •Absence of a history of encephalopathy or refractory ascites
- •Child-Pugh class A or B cirrhosis.
排除标准
- •Poor patient compliance
- •Child-Pugh class C cirrhosis
- •Severe coagulation disorders
- •Portal vein thrombosis
- •Renal impairment (6) previous local ablation therapy of HCC
结局指标
主要结局
Adverse events
时间窗: Up to three years after procedure
Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology
Progression-free survival
时间窗: Three years after procedure
The progression-free survival was measured in relation to management lines.
Recurrence rate
时间窗: 12 months after procedure
The recurrence rate was measured in relation to management lines.
Overall mortality rate
时间窗: Three years after procedure
The mortality rate was measured in relation to management lines.
AFP variation rate
时间窗: Baseline and 1-2 months after procedure
The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation: ΔAFP (%) = \[(AFPbaseline-AFPpostprocedure) /AFPbaseline\] ×100%
Treatment Response
时间窗: One month
Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases.
次要结局
未报告次要终点
研究者
Mohammad Abd Alkhalik Basha
Assistant Professor
Zagazig University