Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Not Applicable
Recruiting
- Conditions
- solid cancer
- Registration Number
- JPRN-UMIN000025834
- 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
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(1) HBs antigen, HCV antibody, HIV antibody are positive. (2) An inappropriate case judged by doctor in charge.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship between the occupancy ratio of immune-checkpoint inhibitors to receptors on peripheral blood CD8 T-lymphocytes and adverse event occurrence in cancer patients with irAE.
- Secondary Outcome Measures
Name Time Method 1)Relationship between the occupancy rate of immune-checkpoint inhibitors in peripheral blood mononuclear cell subsets and adverse events, clinical effects (response rate, progression-free survival). (2)Mononuclear cell fractionation Presence or absence of activation for each cell subtype. (3)Relationship between occurrence of immunological adverse events and response rate and progression-free survival. (4)In cancer patients treated with immune checkpoint inhibitors, searching for factors involved in adverse events and therapeutic effects (such as soluble PD-L1, HLA class I and II).