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

NCT05411926 | Unknown

• 1 other identifier: 21299-4-03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Acute Rejection

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• 5) the overall survival (OS) and relapse-free survival(RFS) after liver transplantation in patients with hepatocellular carcinoma.

  2021-03~2023-03

Study Arms (2)

The group that receiving PD-1 / PD-L1 inhibitor before liver transplantation

The group without receiving PD-1 / PD-L1 inhibitor before liver transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• age between 18 and 70 years,
• Eastern Cooperative Oncology Group (ECOG) performance score ≤3,
• voluntarily participate, totally understand in the study and sign the Informed Consent Form (ICF),
• hepatopathology confirmed hepatocellular carcinoma after liver transplantation, 5）patients with hepatocellular carcinoma treated with PD1/PD-L1 monoclonal antibody prior to liver transplantation,
• ）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)

You may not qualify if:

• patients with incomplete clinicopathological data,
• post-transplantation ≥6months,
• PD-1/PD-L1 monotherapy required for oncological reasons after liver transplantation.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood ， donor liver tissue， diseased liver tissue

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Rui Tang, Ph.D

CONTACT

13811337617; tangrui_hs@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: June 9, 2022
• Study Start: March 17, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 9, 2022

Record last verified: 2022-03

Locations

CN (1)