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临床试验/NCT01033578
NCT01033578Unknown不适用

Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Fudan University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 1999年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).

详细描述

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major cause of cancer-related death. HCC is characterized by its propensity for portal vein invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is dismal. The median survival of such patients was reported to be 2.7 mouths.

Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has been reported to achieve promising results. However, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for HCC with PVTT.

There is rare report about prevention and treatment of postoperative recurrence and metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required further prospective randomized controlled studies with large case number to support our findings. The randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and PVTT.

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
Single (Outcomes Assessor)

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 to 75 years
  • Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology.
  • No extrahepatic metastasis
  • No previous management
  • The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
  • Good or moderate hepatic function (Child-Pugh Class A or B)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

排除标准

  • Refuse to participate
  • Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 * 109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of normal, which could not recover after treatment
  • Ascites refractory to diuretics
  • Variceal bleeding
  • Severe diseases of the heart or Lung

结局指标

主要结局

Overall Survival

时间窗: 1-year, 3-year, 5-year

次要结局

  • Time to Recurrence(1-year, 3-year, 5-year)

研究者

申办方类型
Other

研究点 (1)

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