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

NCT07418138 | Completed

• 1 other identifier: XJTU1AF2025LSYY-775
• Study Type: observational
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation; Hepatocellular Carcinoma (HCC); Tyrosine Kinase Inhibitor; Survival Rate

Keywords

liver transplantation; hepatocellular carcinoma; Tyrosine kinase inhibitor; Survival

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of participants with intraoperative indicators

  Intraoperative

• 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.

Study Arms (2)

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

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

Interventions

Medication history OTHER

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

No TKIs group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hu Liangshuo: lead

Study Sites (1)

First Affiliated Hospital Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: January 1, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)