Hepatocellular Carcinoma, Liver Transplantation
Conditions
Keywords
Checkpoint Inhibitor, Immunotherapy
Brief summary
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.
Interventions
DRUGJS001(PD-1 inhibitor)
240mg I.V. Q3W
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Age 18-70 years old, male or female 3. Biopsy shows negative allograft PD-L1 expression 4. Child-Pugh score ≤ 6 points (Child-Pugh A) 5. Estimated postoperative survival time ≥ 12 weeks 6. ECOG score 0-1 points 7. 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 8. Have sufficient understanding and voluntarily sign informed consent to participate in clinical research
Exclusion criteria
1. Biopsy shows positive allograft PD-L1 expression 2. Severe allergic reactions to other monoclonal antibodies 3. Have any history of active autoimmune diseases or autoimmune diseases 4. The presence of active infection with Hepatitis B or Hepatitis C Virus 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Event Rate | 1.5 years | the occurrence rate of serious adverse event after PD-1 inhibitor treatment |
| Acute Graft Rejection Rate | 1.5 years | the occurrence rate of acute graft rejection after PD-1 inhibitor treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 3 years | Objective Response Rate after PD-1 inhibitor treatment |
| Progression Free Survival Rate | 3 years | survival time after PD-1 inhibitor treatment till tumor progression |
| Over all survival Rate | 3 years | survival time after PD-1 inhibitor treatment till patient death |
Countries
China
Contacts
Primary ContactXiaowu Huang, M.D.
Outcome results
None listed