hepatocellular carcinoma
Conditions
Interventions
Control group:Baliximab drugs as immune induction agents
Research Group:ATG drugs as immune induction agents
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent form, regardless of gender; 2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 3. Histologically and/or cytologically confirmed hepatocellular carcinoma; 4. Patients undergoing liver transplantation for the first time; 5. Received >=1 dose of PD-1 inhibitor treatment prior to liver transplantation (whole liver transplantation); 6. The interval between the last PD-1 inhibitor treatment and the transplantation surgery is >=30 days and <=180 days; 7. Fully understand this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received systemic and/or local autologous and/or allogeneic cell therapy prior to surgery; 2. Received immunotherapy other than immune checkpoint inhibitors (ICIs) prior to surgery; 3. Pre-existing autoimmune diseases or immunodeficiency disorders; 4. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; 5. Uncontrolled comorbidities including but not limited to active infections, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other conditions deemed ineligible by the investigator; 6. Patients who are lactating or pregnant; 7. History of substance abuse; clinical, psychological, or social factors that may affect informed consent or study implementation, history of psychiatric disorders; 8. History of or investigator-documented allergy to immunoglobulins; 9. Patients deemed ineligible by the investigator or unable to complete the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of acute rejection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical infection rate at 3 months post-surgery;1 year patient survival and graft survival; | — |
Countries
China
Contacts
Public ContactWei Zhang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed