Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
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
- 否
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
details in the "Intervention Description"
干预措施: folfox4 chemotherapy regimen (Drug)
Placebo
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
Jiazhou Ye
M.D.
Guangxi Medical University
