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

Zhejiang University

Status: Not yet enrolling

Conditions: Protein Induced by Vitamin K Absence or Antagonist-II; Liver Transplantation; Alpha-Fetoprotein; Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06331260

CT2024-ZJU-OBS2

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. 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

Trial design

600 participants in 2 patient groups

Preoperative AFP < 400 ng/mL or PIVKA-II < 200mAU/mL

Preoperative AFP ≥ 400 ng/mL and PIVKA-II ≥ 200mAU/mL