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临床试验/NCT03985644
NCT03985644Unknown不适用

Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma

Zhejiang University0 个研究点目标入组 500 人开始时间: 2019年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
Overall survival

研究概览

简要总结

Liver transplantation is an optimal radical therapy for selected patients with hepatocellular carcinoma. Hangzhou criteria could safely and effectively expand Milan criteria with expanded population and comparable survival. The purpose of this study was to evaluate the Hangzhou criteria in a multi-center cohort.

详细描述

Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer-related deaths worldwide. Among all the liver cancer cases, hepatocellular carcinoma (HCC) constitutes 75-85%. Liver transplantation is the most effective treatment for HCC and is in high demand in China. The advent of Milan criteria has helped to select the recipients reasonably. However, the organ allocation system driven by the Milan criteria seemed to be too strict so that many centers worldwide have expanded the criteria in the aspects of morphological features, histopathology and biomarkers. Hangzhou criteria introduce the covariables of histopathologic grading and α-fetoprotein (AFP) into the selection of recipients for the first time. Based on the multi-center HCC patient cohort undergoing transplantation, this study aims to characterize an ideal candidate selecting system beyond the Milan criteria.

研究设计

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

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

  • Aged ≥18 years and <=75 with HCC confirmed by histopathology;
  • Undergoing a primary whole or split liver transplant from a deceased donor;

排除标准

  • Incomplete follow-up;
  • Missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) ;
  • Vascular invasion according to radiological criteria;
  • Perioperative mortality (<30 days) ;

结局指标

主要结局

Overall survival

时间窗: 5 years

Overall survival

次要结局

  • Recurrence rate(5 years)

研究者

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

Xiao Xu

professor

Zhejiang University

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