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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group that receiving PD-1 / PD-L1 inhibitor before liver transplantation | |||
| The group without receiving PD-1 / PD-L1 inhibitor before liver transplantation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma. | 2021-03~2023-03 |
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Inclusion Criteria:
6)PD-1/PD-L1 monotherapy needs to be used ≥ 2 times (The patients were divided into observation and control group according to whether received PD-1/PD-L1 monoclonal antibody treatment before liver transplantation)
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Tang, Ph.D | Contact | 13811337617 | tangrui_hs@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 102218 | China |
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peripheral blood , donor liver tissue, diseased liver tissue
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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