NCT02038296已完成3 期
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
- •HCC with no previous treatment;
- •age between 18 and 75 years;
- •Life expectancy of at least 8 weeks;
- •main tumor size greater than 5 cm;
- •adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
- •adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
- •Child-Pugh classification A or B grade;
- •Barcelona Clinic Liver Cancer (BCLC) stage B or C;
- •Eastern Co-operative Group performance status of zero or one.
排除标准
- •a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
- •diffuse-type HCC;
- •evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
- •severe underlying cardiac or renal diseases;
- •color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.
研究组 & 干预措施
Group 1
Experimental
Group 1 received single-drug (doxorubicin)transarterial chemoembolization.
干预措施: transarterial chemoembolization (Procedure)
Group 2
Experimental
Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization
干预措施: transarterial chemoembolization (Procedure)
Group 3
Experimental
Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.
干预措施: transarterial chemoembolization (Procedure)
结局指标
主要结局
overall survival
时间窗: 1-2 year
次要结局
未报告次要终点
研究者
研究点 (1)
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