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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06331260
Enrollment
600
Registered
2024-03-26
Start date
2024-04-01
Completion date
2028-04-01
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

None listed

Sponsors

Shulan (Hangzhou) Hospital
CollaboratorOTHER
Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrence free survival rate2024.4.1-2028.4.1
Overall survival rate2024.4.1-2028.4.1
Tumor recurrence rate2024.4.1-2028.4.1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026