Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma

As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.

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Key information

Conditions

Liver Transplantation Adenocarcinoma Alpha-Fetoprotein Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Protein Induced by Vitamin K Absence or Antagonist-II

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
Patients undergoing deceased donor liver transplantation for the first time.

Exclusion criteria

(1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up, (5) taking warfarin at the time of LT biomarker measurements

Treatment and study plan

Primary outcomes

Recurrence free survival rate

Time frame: 2024.4.1-2028.4.1
Overall survival rate

Time frame: 2024.4.1-2028.4.1
Tumor recurrence rate

Time frame: 2024.4.1-2028.4.1

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

Shulan (Hangzhou) Hospital

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Mar 26, 2024
Registry last updated: Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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