Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant

Study Overview
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Brief Summary
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This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment. Biopsy is needed to exclude patients with positive allograft PD-L1 expression.

Official Title
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Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations

Conditions
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Hepatocellular Carcinoma, Liver Transplantation

Intervention / Treatment
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* Drug: JS001(PD-1 inhibitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment. Age 18-70 years old, male or female Biopsy shows negative allograft PD-L1 expression Child-Pugh score ≤ 6 points (Child-Pugh A) Estimated postoperative survival time ≥ 12 weeks ECOG score 0-1 points Laboratory test indicators: white blood cells ≥ 3.0 × 109 / L, platelets ≥ 80 × 109 / L, hemoglobin ≥ 100g / L; total bilirubin ≤ 2.5 times the upper limit of normal, transaminase (AST, ALT) ≤ 2.5 times Upper limit of normal value, serum creatinine ≤ 1.5 times normal upper limit Have sufficient understanding and voluntarily sign informed consent to participate in clinical research Exclusion Criteria: Biopsy shows positive allograft PD-L1 expression Severe allergic reactions to other monoclonal antibodies Have any history of active autoimmune diseases or autoimmune diseases The presence of active infection with Hepatitis B or Hepatitis C Virus Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>JS001（PD-1 inhibitor）, 240mg I.V. Q3W, | Drug: JS001(PD-1 inhibitor)<br>* 240mg I.V. Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Event Rate | the occurrence rate of serious adverse event after PD-1 inhibitor treatment | 1.5 years | 
| Acute Graft Rejection Rate | the occurrence rate of acute graft rejection after PD-1 inhibitor treatment | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective Response Rate after PD-1 inhibitor treatment | 3 years | 
| Progression Free Survival Rate | survival time after PD-1 inhibitor treatment till tumor progression | 3 years | 
| Over all survival Rate | survival time after PD-1 inhibitor treatment till patient death | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Checkpoint Inhibitor, Immunotherapy