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临床试验/NCT01600196
NCT01600196终止4 期

Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2006年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
发起方
入组人数
126
试验地点
1
主要终点
Survival time

研究概览

简要总结

The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.

详细描述

Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.

研究设计

研究类型
Interventional
分配方式
Non 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

  • The diagnosis of HCC was made according to AASLD guidelines
  • Main tumor ≥ 7 cm
  • Imaging confirmed the presence of PVTT in the first branches but not
  • Extend into the main trunk of portal vein
  • Eastern Co-operative Group performance
  • Resectable disease

排除标准

  • Child-Pugh class B or C liver cirrhosis
  • An American Society of Anesthesiologists (ASA) score ≥ 3
  • Extrahepatic metastasis
  • Patients had access to sorafenib.

研究组 & 干预措施

Resection arm

Experimental

Liver resection Plus Thrombectomy

干预措施: Liver resection plus Thrombectomy (Procedure)

Best support care arm

No Intervention

Best supportive care

结局指标

主要结局

Survival time

时间窗: 5-years

次要结局

  • Number of Adverse Events(30 days)

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

Shi Ming

Professor

Sun Yat-sen University

研究点 (1)

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