Multi-center Clinical Application of Hangzhou Criteria in Liver Transplantation for Hepatocellular Carcinoma

• Conditions: HCC; Liver Transplantation

• Registration Number: NCT03985644
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-12
• Last Update Submitted: 2019-06-12
• Study First Posted: 2019-06-14
• Last Update Posted: 2019-06-14
• Study Start: 2019-07
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• 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) ;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	5 years	Recurrence rate