thymic carcinoma
Conditions
Interventions
Administration of 3 mg/kg of nivolumab every two weeks as an intravenous infusion
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with thymic carcinoma confirmed by tissue or cytological diagnosis 2)Correspond to any of the following a. Unresectable Masaoka-Koga classification IIIa or IIIb thymic carcinoma b. Masaoka-Koga classification IVa or IVb thymic carcinoma c. Recurrent thymic carcinoma 3)Aged 20 or above at the time of registration 4)Performance Status 0 or 1 5)Patients who had received at least one previous platinum-based chemo (radio) therapy 6)Patients who had not received systematic corticosteroid at a daily dose of more than 10 mg in prednisolone equivalent or immunosuppressant drug within 14 days before registration 7)Patients who had not received anti-cancer drug or other study drug within 28 days before registration 8)Patients with the following values in laboratory tests performed within 14 days before registration, provided that they had not received G-CSF or blood transfusion within 14 days before the blood collection a. Neutrophil count >=1500 / mm3 b. Platelet count>=100000 / mm3 c. Hemoglobin>=9.0 g/dL d. AST<=100 U/L e. ALT<=100 U/L f. Total bilirubin<=1.5 mg/dL g. Creatinine<=0.5 mg/dL 9)Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration 10)Patients gave written informed consent for this trial
Exclusion criteria
Exclusion criteria: 1)Patients with active double cancer (except for completely resected basal cell cancer, stage I squamous cell cancer, carcinoma in situ, intramucosal cancer, superficial bladder cancer, or gastrointestinal cancer resected by ESD or EMR, or other cancer free of relapse for 5 years) 2)Patients who have an infection requiring systematic therapy 3)Patients with active gastrointestinal ulceration 4)Patients with current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings 5)Patients with a current or previous severe hypersensitive reaction to an antibody product 6)Patients with a current or chronic and recurrent auto immune disease (Patients could be enrolled if they had type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorder requiring no systematic therapy, or an auto immune disease predicted to remain free of disease in the absence of external factors) 7)Patients who are HIV antibody-positive, HBsAg-positive, or HCV antibody-positive (even though a patient was HCV antibody-positive, the patient could be enrolled if the patient was HCV-RNA-negative) 8)Patients who are HBsAg-negative, but HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test is positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Patients with a psychiatric disease or psychological symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Countries
Japan
Contacts
Public ContactTamie Sukigara
National Cancer Center Hospital Clinical Trial Support Office
Outcome results
None listed