Efficacy and Safety of Pre-Transplant Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma Patients Undergoing Liver Transplantation
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
Hu Liangshuo
Principal Investigator
First Affiliated Hospital Xi'an Jiaotong University