NCT05411926|Unknown
Loading search results
Sponsor study identifier
observational
30
1 country
1
Study Start
March 17, 2021
Actual (reported)Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is a single-center, prospective, non-interventional cohort study based on the real world data.In this study, 30 patients with a history of PD-1/PD-L1 monotherapy prior to liver transplantation and 30 patients without a history of PD-1/PD-L1 monotherapy prior to liver transplantation were recruited from the group of patients with hepatocellular carcinoma who had undergone allogeneic liver transplantation.Collected patient data included demographics, oncology and immunotherapy history, evaluated index before liver transplantation, laboratory, pathological and imaging results at specific time points after transplantation (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 16 weeks, 24 weeks), as well as the occurrence of acute rejection (AR) , grading of severity, and anti-rejection treatment plan at the same time. Endpoints included relapse-free survival and overall survival (OS). These data aims to assess: 1) the incidence of acute rejection after liver transplantation in patients with hepatocellular carcinoma; 2) the time of acute rejection, Banff classification, and acute rejection-related mortality after liver transplantation in patients with hepatocellular carcinoma; 3) the cellular immune function after liver transplantation;; 4) the dose and drug concentration of tacrolimus after liver transplantation in patients with hepatocellular carcinoma; and 5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2021
Actual (reported)April 20, 2022
Actual (reported)June 9, 2022
Actual (reported)March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
1) the incidence of acute rejection after liver transplantation in patients with hepatocellular carcinoma;
2021-03~2023-03
2) the severity of acute rejection after liver transplantation in patients with hepatocellular carcinoma;
2021-03~2023-03
3) the cellular immune function after liver transplantation，including lymphocyte subsets and cytokines
2021-03~2023-03
4) the dose and drug concentration of tacrolimus after liver transplantation in patients with hepatocellular carcinoma;
2021-03~2023-03
5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma.
2021-03~2023-03
Patients with hepatocellular carcinoma who had undergone allogeneic liver transplantation.In this study, 30 patients with a history of PD-1/PD-L1 monotherapy prior to liver transplantation and 30 patients without a history of PD-1/PD-L1 monotherapy prior to liver transplantation were recruited from the group of patients with hepatocellular carcinoma who had undergone allogeneic liver transplantation.
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
peripheral blood ， donor liver tissue， diseased liver tissue
First Submitted
April 20, 2022
First Posted
June 9, 2022
Study Start
March 17, 2021
Actual (reported)Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: