Liver TransplantationNCT07418138
Effect of Pre-Transplant Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma Patients With Liver Transplantation
An observational study of Liver Transplantation and Hepatocellular Carcinoma (HCC), run by Hu Liangshuo at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation, Hepatocellular Carcinoma (HCC), Tyrosine Kinase Inhibitor
- What is being tested?
- Medication history
- How many people
- 484 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma (HCC), Tyrosine Kinase Inhibitor, Survival Rate
- Being tested
- Medication history
- Keywords
- liver transplantation, hepatocellular carcinoma, Tyrosine kinase inhibitor, Survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication historyOther
The study was retrospective and did not involve the application of interventions.
Medication historyOther
The study was retrospective and did not involve the application of interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Medication history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative survival time
Postoperative survival time for patients receiving liver transplantation
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: Intraoperative
Post-operative complications in patients who underwent liver transplantation
Specific details of all post-operative complications in patients who underwent liver transplantation
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hu Liangshuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418138
- Sponsor's protocol ID
- XJTU1AF2025LSYY-775
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Xu L, Zhao Z, Wang Z, Zhao Z, Mu F, Zhou C, Ye Z, Zhang X, Wang Y, Lan T, Cao W, Zhang Y, Qi J, Hou Y, Shi J, Lu J, Tian M, Lv Y, Qu P, Hu L, Wang B. Association of Pre-Transplant Tyrosine Kinase Inhibitor Therapy With Tumor Response and Survival in Hepatocellular Carcinoma: A 10-Year Retrospective Cohort Study of 427 Patients. World J Surg. 2026 Jul 9. doi: 10.1002/wjs.70454. Online ahead of print.
PubMed 42421575
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pre-Transplant Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT07418138
- Acronym / sponsor ID
- XJTU1AF2025LSYY-775
- Conditions
- Liver Transplantation, Hepatocellular Carcinoma (HCC), Tyrosine Kinase Inhibitor, Survival Rate
- Keywords
- liver transplantation, hepatocellular carcinoma, Tyrosine kinase inhibitor, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Hu LiangshuoUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKIs group | – | Other: Medication historyThe 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. |
| No TKIs group | – | Other: Medication historyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication historyThe study was retrospective and did not involve the application of interventions. | Other | No TKIs group |
| Medication historyThe study was retrospective and did not involve the application of interventions | Other | TKIs group |
Primary outcome
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.
2 secondary outcomes
Number of participants with intraoperative indicators
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 42421575Xu L, Zhao Z, Wang Z, Zhao Z, Mu F, Zhou C, Ye Z, Zhang X, Wang Y, Lan T, Cao W, Zhang Y, Qi J, Hou Y, Shi J, Lu J, Tian M, Lv Y, Qu P, Hu L, Wang B. Association of Pre-Transplant Tyrosine Kinase Inhibitor Therapy With Tumor Response and Survival in Hepatocellular Carcinoma: A 10-Year Retrospective Cohort Study of 427 Patients. World J Surg. 2026 Jul 9. doi: 10.1002/wjs.70454. Online ahead of print.
- Individual participant dataSharing planned: No. 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.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Hepatocellular Carcinoma (HCC), run by Hu Liangshuo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.