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Completed

NCT Number: NCT07418138

Effect of Pre-Transplant Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma Patients With Liver Transplantation

Based on the follow-up data of hepatocellular carcinoma (HCC) patients undergoing liver transplantation from the China Liver Transplant Registry (CLTR) and the First Affiliated Hospital of Xi'an Jiaotong University, patients who met the inclusion criteria were assessed for tumor response, post-transplant tumor recurrence, and survival rates. Statistical analysis was performed to evaluate patient prognosis and to identify risk factors affecting outcomes.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

A retrospective study was performed on patients who underwent liver transplant for hepatocellular carcinoma (HCC) at the First Affiliated Hospital of Xi'an Jiaotong University between January 2015 and December 2024. Clinical data including demographic characteristics, tumor characteristics, detailed history of pre-transplant antitumor therapy, perioperative laboratory parameters, surgical details, and pathological findings were collected from the hospital's prospective clinical database. Based on follow-up records, patients who met the inclusion criteria were evaluated for tumor response, post-transplant tumor recurrence and overall survival. Statistical analyses were conducted to assess postoperative prognosis and to identify risk factors associated with clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years and ≤ 75 years;
  • HCC diagnosis confirmed through imaging and elevated serum alpha-fetoprotein (AFP);
  • Underwent liver transplantation for hepatocellular carcinoma.
  • Underwent primary (first-time) liver transplantation.
  • Availability of complete clinical and follow-up data for analysis.

Exclusion criteria

  • age <18 years or >75 years;
  • living-donor liver transplantation or re-transplantation;
  • concurrent active malignancy other than HCC;
  • incomplete key baseline data or follow-up information.

Treatment and study plan

Medication history

Other

The study was retrospective and did not involve the application of interventions.

Primary outcomes

  1. Post-operative survival time

    Time frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2024. whichever came first, assessed up to 60 months.

    Postoperative survival time for patients receiving liver transplantation

  2. Recurrence of the primary disease after surgery

    Time frame: The time period between liver transplantation and the initial examination revealing a recurrence of primary disease, or until the end of follow-up on December 31, 2024.whichever came first, assessed up to 60 months.

    Recurrence of primary disease in patients who underwent liver transplantation after surgery

  3. Transplanted liver status

    Time frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2024. whichever came first, assessed up to 60 months.The functional status of the transplanted liver was recorded during this period.

    Postoperative Liver Function in Patients Undergoing Liver Transplantation. To monitor post-transplant liver status regularly through assessment of key liver function biochemical indices (including AST, ALT, bilirubin, etc.) and liver imaging examinations.

Secondary outcomes

  1. Number of participants with intraoperative indicators

    Time frame: Intraoperative

    Record important intraoperative indicators during the transplantation procedure, including operative time, warm ischemia time, cold ischemia time, anhepatic phase duration, intraoperative blood loss, volume of red blood cells transfused, and total intravenous fluid volume.

  2. Post-operative complications in patients who underwent liver transplantation

    Time frame: Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2024. whichever came first, assessed up to 60 months.During this period, all postoperative complications of the patient will be recorded.

    Specific details of all post-operative complications in patients who underwent liver transplantation

Sponsors and collaborators

Lead sponsor

Hu Liangshuo

Other

Registry information

Official study title

Efficacy and Safety of Pre-Transplant Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma Patients Undergoing Liver Transplantation

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

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.

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