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

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

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Hepatocellular Carcinoma (HCC); Survival Rate; Tyrosine Kinase Inhibitor
• Intervention / Treatment: Other: Medication history; Other: Medication history

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 484

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2024, were retrospectively identified using the China Liver Transplant Registry (CLTR) and clinical data in the First Affiliated Hospital of Xi'an Jiaotong University

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TKIs group; The TKIs group was defined as patients who received at least 28 days of tyrosine kinase inhibitor therapy (including sorafenib, lenvatinib, regorafenib, or donafenib) prior to liver transplantation. According to the inclusion and exclusion criteria, subjects meeting this group's characteristics were screened from the database, and the group's data were collected and recorded for subsequent analysis.	Other: Medication history; The study was retrospective and did not involve the application of interventions; Other: Medication history; The study was retrospective and did not involve the application of interventions.
No TKIs group; The No TKIs group was defined as patients who did not receive tyrosine kinase inhibitor therapy (including sorafenib, lenvatinib, regorafenib, or donafenib) prior to liver transplantation. According to the inclusion and exclusion criteria, subjects meeting this group's characteristics were screened from the database, and the group's data were collected and recorded for subsequent analysis.	Other: Medication history; The study was retrospective and did not involve the application of interventions; Other: Medication history; The study was retrospective and did not involve the application of interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative survival time	Postoperative survival time for patients receiving liver transplantation	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.
Recurrence of the primary disease after surgery	Recurrence of primary disease in patients who underwent liver transplantation after surgery	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.
Transplanted liver status	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with intraoperative indicators	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.	Intraoperative
Post-operative complications in patients who underwent liver transplantation	Specific details of all post-operative complications in patients who underwent liver transplantation	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.

Collaborators and Investigators

• Sponsor: Hu Liangshuo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Survival; liver transplantation; hepatocellular carcinoma; Tyrosine kinase inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Pharmaceutical Preparations
• Other Study ID Numbers: XJTU1AF2025LSYY-775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study was based on database from the The First Affiliated Hospital of Xi'an Jiao Tong University and the Chinese Liver Transplant Registry, researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No