Clinical trial NCT03985644: Multi-center Clinical Application of Hangzhou Criteria in Liver Transplantation for Hepatocellular Carcinoma
Official title: Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCC
Liver Transplantation
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

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) ;

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Other outcomes:
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