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临床试验/NCT02813096
NCT02813096Unknown不适用

Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection

Guangxi Medical University0 个研究点目标入组 500 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
early recurrence

研究概览

简要总结

This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection

详细描述

Curative resective is well-accepted as the predominant treatment for hepatocellular carcinoma (HCC) patients. Unfortunately, the long-term prognosis remains poor due to frequent postoperative recurrence, especially in HCC patients with portal vein tumor thrombus (PVTT). When PVTT invades into the portal vein system, tumor cell spreads and distributes along with the portal vein and its branches,thus resulting in intra-hepatic micro-metastasis which contributes to early recurrence for patients following curative resection. Postoperative adjuvant interventions include TACE, antiviral therapy, immunotherapy, local radiotherapy were applied to prevent recurrence. However, the efficacy and safety of these regimens remains unsatisfactory. Thus new therapeutic strategy remains to be investigated. This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for HCC patients with PVTT following curative resection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergo curative resection
  • HCC with PVTT is confirmed by pathological examination
  • patients undergo chemotherapy of Folfox4 regimen
  • patients without recurrence within the first month after curative resection
  • residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy
  • patients without other postoperative adjuvant treatments including TACE, radiotherapy, immunotherapy

排除标准

  • Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection
  • patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy
  • patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen
  • patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course

研究组 & 干预措施

folfox4 chemotherapy regimen

Experimental

details in the "Intervention Description"

干预措施: folfox4 chemotherapy regimen (Drug)

Placebo

Placebo Comparator

details in the "Intervention Description"

干预措施: Placebo (Other)

结局指标

主要结局

early recurrence

时间窗: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years

次要结局

  • overall survival(from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years)

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiazhou Ye

M.D.

Guangxi Medical University

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