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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03985644
• Other study ID #: zju2017xux
• Status: Not yet recruiting
• Start date: July 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, a-fetoprotein (AFP)) ;

• Vascular invasion according to radiological criteria;

• Perioperative mortality (<30 days) ;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC
• Liver Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival	5 years
Secondary	Recurrence rate	Recurrence rate	5 years