Prospective study on Pharmacodynamics, the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with immune-checkpoint inhibitor.
Not Applicable
Recruiting
- Conditions
- solid cancer
- Registration Number
- JPRN-UMIN000025796
- Lead Sponsor
- Department of Internal Medicine,Division of Medical Oncology, Showa University School of Medicine.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of severe hypersensitivity to drugs used in this study. (2) Within 14 days administer other antineoplastic agent before treatment of immune checkpoint inhibitors. (3) Active infection. (4) HBs antigen, HCV antibody and HIV antibody is positive. (5) Pregnacy or patient's hope to be pregnant. (6) An inappropriate case judged by doctor in charge.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.
- Secondary Outcome Measures
Name Time Method Identify autoantigens that cause immunological adverse events.To confirm whether thyroid autoantibodies are predictors of thyroid dysfunction. Relationship between immunological adverse event and response rate, duration of response, progression-free survival time, overall survival time, PD-L1, HLA class I, II . The relationship between immune-related proteins (PD-L1) expression of tumor tissue and predictions of therapeutic effect and irAE.