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临床试验/NCT01833286
NCT01833286Unknown3 期

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Re-resection for Recurrent Hepatocellular Carcinoma

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
200
试验地点
1
主要终点
overall survival

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. Our previous retrospective study demonstrated that RFA was comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial hepatectomy.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 - 75 years;
  • recurrence of HCC 12 months after initial hepatectomy;
  • no other treatment received except for the initial hepatectomy;
  • Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
  • lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  • no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
  • Eastern Co-operative Oncology Group performance(ECOG) status 0 -1

排除标准

  • the presence of vascular invasion or extrahepatic spread on imaging;
  • a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • an American Society of Anesthesiologists (ASA) score ≥ 3 -

结局指标

主要结局

overall survival

时间窗: 5 year

次要结局

  • disease-free survival(5 year)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Min-Shan

professor

Sun Yat-sen University

研究点 (1)

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