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

February 17, 2026 updated by: Hu Liangshuo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
484

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Intraoperative
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hu Liangshuo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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