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临床试验/NCT02309788
NCT02309788Unknown不适用

Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
overall survival

研究概览

简要总结

Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • HCC with no preoperative RT
  • resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function
  • compensated cirrhosis or no cirrhosis; Child-Pugh A
  • ECOG Performance Status of 0 or
  • Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry

排除标准

  • unresectable hepatocellular carcinoma patients
  • Hepatocellular carcinoma without portal vein tumor thrombus
  • Hepatectomy without narrow margin(more than 1cm)
  • presence of distant metastasis
  • palliative resection with tumor residual
  • non-HCC confirmed by postoperative pathology

结局指标

主要结局

overall survival

时间窗: 1year

次要结局

未报告次要终点

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

TaoBai

Researcher

Guangxi Medical University

研究点 (1)

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