An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab.
Not Applicable
Recruiting
- Conditions
- solid cancer
- Registration Number
- JPRN-UMIN000028474
- 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
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
(1) HBs antigen, HCV antibody and HIV antibody is 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 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 The elationship between peripheral blood T cell subsets and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between microflora of the gastrointestinal tract, oral cavity, and blood and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate. The relationship between PD-L1 expression of tumor tissue and predictions of therapeutic effect (response rate, 6-month progression free survival rate, and 1 year survival rate) and irAE.