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

Zhejiang University

Status: Unknown

Conditions: Liver Transplantation; HCC

Study type: Observational

Funder types: Other

Identifiers

NCT03985644

zju2017xux

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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) ;

Trial design

500 participants in 2 patient groups

Fulfilling Hangzhou criteria

Description:

Patients flfilling Hangzhou critieria: Without macrovascular invasion Tumor burden \<=8 cm Preoperative AFP level \<=400 ng/mL Histopathologic grades I, II

Exceeding Hangzhou criteria

Description:

Patients exceeding Hangzhou critieria