NCT00357474已完成3 期
A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- overall survival rate
研究概览
简要总结
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.
详细描述
To compare the below things between PEIT group and TACE group
-
Survival
-
5 year overall survival rate
-
Disease free survival rate
-
Recurrence a. recurrence rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis
- •Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
- •The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
- •Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
- •It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)
排除标准
- •In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
研究组 & 干预措施
chemotherapy
Active Comparator
Transarterial chemoembolization (TACE)
干预措施: Transarterial chemoembolization (Procedure)
ethanol
Active Comparator
Percutaneous ethanol injection therapy (PEIT)
干预措施: Percutaneous ethanol injection therapy (Procedure)
结局指标
主要结局
overall survival rate
时间窗: 5 year
次要结局
- Disease free survival rate and recurrence rate(5 year)
研究者
Jung-Hwan Yoon
Professor
Seoul National University Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparison Study of Operation and PEIT for Small, Solitary Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT00357422Seoul National University Hospital36
已完成
2 期
Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/VelpatasvirAcute Hepatitis CHepatitis CNCT03818308Hannover Medical School20
Unknown
不适用
Treatment for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring SystemHepatocellular CarcinomaNCT02525952Eastern Hepatobiliary Surgery Hospital320
招募中
2 期
A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCCMacrotrabecular Massive Hepatocellular CarcinomaNCT05839197Wan-Guang Zhang38
招募中
不适用
Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade DysplasiaBarrett EsophagusEsophageal AdenocarcinomaNCT05753748University of Colorado, Denver680