Clinical trial NCT03966209: Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant
Official title: Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Liver Transplantation
Keywords: Checkpoint Inhibitor
Immunotherapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Event Rate
timeFrame: 1.5 years
measure: Acute Graft Rejection Rate
timeFrame: 1.5 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 3 years
measure: Progression Free Survival Rate
timeFrame: 3 years
measure: Over all survival Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
References: