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

NCT ID: NCT03985644

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-12-31

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.

Conditions

HCC; Liver Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fulfilling Hangzhou criteria

Patients flfilling Hangzhou critieria:

Without macrovascular invasion Tumor burden <=8 cm Preoperative AFP level <=400 ng/mL Histopathologic grades I, II

No interventions assigned to this group

Exceeding Hangzhou criteria

Patients exceeding Hangzhou critieria

No interventions assigned to this group

Eligibility Criteria

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) ;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

zju2017xux

Identifier Type: -

Identifier Source: org_study_id