Correlation Between Pre-transplant ICI Exposure and Post-transplant Graft Rejection

Trial Title: Correlation Between Pre-transplant ICI Exposure and Post-transplant Graft Rejection

NCT ID: NCT05913583

Condition: Graft Rejection
Hepatocellular Carcinoma
Immunotherapy
Immune Checkpoint Inhibitor

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Immune Checkpoint Inhibitors

Conditions: Keywords:
hepatocellular carcinoma
liver transplantation
Immune checkpoint inhibitor
Graft rejection

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Drug
Intervention name: Immune checkpoint inhibitor
Description: Immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the "off" signal from being sent, allowing the T cells to kill cancer cells.One such drug acts against a checkpoint protein called CTLA-4. Other immune checkpoint inhibitors act against a checkpoint protein called PD-1 or its partner protein PD-L1.
Arm group label: ICI group

Other name: Anti-PD-1; Anti-PD-L1; Anti-CTLA-4

Summary: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced HCC. The combination of the ICI and other treatment regimens (Anti-VEGF, locoregional therapies et al) produced superior results in patients with advanced-stage HCC compared to those treated with traditional therapeutic regimens. Liver transplantation (LT) offers excellent long-term outcomes for certain patients with HCC. However, the immune-stimulating property of ICIs may lead to rejection and even graft loss, damping their use in treating HCC before liver transplantation. Therefore, it is worthwhile to explore the relationship between exposure to ICIs before LT and the incidence of graft rejection and rejection-related death or graft loss after LT.

Detailed description: This will be a retrospective and observational study, which will analyze the correlation between the use of ICIs and incidences of graft rejection and rejection-related death or graft loss after LT in consecutive recipients with LT for HCC at the Organ Transplantation Center of Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The primary aim of this study is to analyze the correlation between pretransplant exposure to ICIs and incidences of graft rejection and rejection-related death or graft loss within 1 year after liver transplantation. The secondary aim is to analyze the risk factors for graft rejection and to explore the correlation between ICI exposure and posttransplantation complication, such as incidences of early allograft dysfunction (EAD), bleeding, infection, biliary and vascular complications et al. The exploratory aim is to identify potential biomarkers in predicting graft rejection, such as subsets of lymphocytes and cytokines et al.

Criteria for eligibility:

Study pop:
A retrospective cohort study will be performed on consecutive HCC patients who underwent LT for HCC. The pretransplant parameters, such as AFP, tumor status, BMI, and etiology et al, as well as posttransplant parameters, such as graft rejection, EAD, hospital death et al, will be analyzed.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria 1. Written informed consent must be obtained prior to any data collection. 2. Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma based on the AASLD practice guidelines. 3. All patients receiving liver transplantation for HCC. Exclusion Criteria 1. Cholangiocellular carcinoma, combined hepatocellular and cholangiocarcinoma, and other rare types of liver cancer that are confirmed by histology/cytology. 2. Patients with incomplete follow-up data

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Organ Transplantation Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

Address:
City: Guangzhou
Zip: 376032
Country: China

Status: Recruiting

Contact:
Last name: Li PANG, PhD

Phone: 13622860325
Email: leepang@connect.hku.hk

Investigator:
Last name: Chao LIU, PhD
Email: Principal Investigator

Start date: April 1, 2023

Completion date: September 1, 2023

Lead sponsor:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05913583