Effect of PD-1 /PD-L1 Inhibitor Therapy Before Liver Transplantation on Acute Rejection After Liver Transplantation in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Effect of PD-1 /PD-L1 Inhibitor Therapy Before Liver Transplantation on Acute Rejection After Liver Transplantation in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411926
• Other study ID #: 21299-4-03
• Status: Recruiting
• Start date: March 17, 2021
• Est. completion date: September 2023

Study information

• Verified date: March 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Rui Tang, Ph.D
• Phone: 13811337617
• Email: tangrui_hs[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 70 years,

2. Eastern Cooperative Oncology Group (ECOG) performance score =3,

3. voluntarily participate, totally understand in the study and sign the Informed Consent Form (ICF),

4. hepatopathology confirmed hepatocellular carcinoma after liver transplantation, 5)patients with hepatocellular carcinoma treated with PD1/PD-L1 monoclonal antibody prior to liver transplantation,

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:

1. patients with incomplete clinicopathological data,

2. post-transplantation =6months,

3. PD-1/PD-L1 monotherapy required for oncological reasons after liver transplantation.

Related Conditions & MeSH terms

• Acute Rejection
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) the incidence of acute rejection after liver transplantation in patients with hepatocellular carcinoma;		2021-03~2023-03
Primary	2) the severity of acute rejection after liver transplantation in patients with hepatocellular carcinoma;		2021-03~2023-03
Primary	3) the cellular immune function after liver transplantation,including lymphocyte subsets and cytokines		2021-03~2023-03
Primary	4) the dose and drug concentration of tacrolimus after liver transplantation in patients with hepatocellular carcinoma;		2021-03~2023-03
Secondary	5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma.		2021-03~2023-03