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

NCT ID: NCT05411926

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-17

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Acute Rejection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rui Tang, Ph.D

Role: CONTACT

13811337617

Facility Contacts

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Rui Tang

Role: primary

13811337617

Yucheng Hou

Role: backup

18210899959

Other Identifiers

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21299-4-03

Identifier Type: -

Identifier Source: org_study_id

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