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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03985644
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Xiao Xu, 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.

Condition or disease
HCC Liver Transplantation

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Fulfilling Hangzhou criteria

Patients flfilling Hangzhou critieria:

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

Exceeding Hangzhou criteria
Patients exceeding Hangzhou critieria

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Overall survival

Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: 5 years ]
    Recurrence rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged ≥18 years and <=75 with HCC who underwent a primary whole or split liver transplant from a deceased donor were eligible for enrollment at the time of transplant. All of patients were histologically confirmed HCC by postoperative pathological examination in the participating centers. The donor-to-recipient arrangements all conformed to the principle of ABO compatibility. Key exclusion criteria were incomplete follow-up, missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) or vascular invasion according to radiological criteria, and excludes those with perioperative mortality (<30 days)

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) ;

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Responsible Party: Xiao Xu, professor, Zhejiang University Identifier: NCT03985644     History of Changes
Other Study ID Numbers: zju2017xux
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases