Skip to main content
Clinical Trials/NCT07418138
NCT07418138CompletedNot Applicable

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

Hu Liangshuo1 site in 1 country484 target enrollmentStarted: January 1, 2015Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
484
Locations
1
Primary Endpoint
Post-operative survival time

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Medication history (Other)

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.

Intervention: Medication history (Other)

Outcomes

Primary Outcomes

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

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

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

  • 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.)

Investigators

Sponsor
Hu Liangshuo
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hu Liangshuo

Principal Investigator

First Affiliated Hospital Xi'an Jiaotong University

Study Sites (1)

Loading locations...

Similar Trials