Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma)
Not Applicable
Recruiting
- Conditions
- malignant tumors
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 5 years or less * Patients with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is judged to have been cured by local treatment are not excluded. 2) Patients with concomitant psychosis or psychiatric symptoms who are judged to have difficulty participating in the study 3) Patients who have received systemic administration of steroids within the last 4 weeks. * The use of topical steroids is acceptable. (4) Other patients who are judged inappropriate for participation in this study by the principal investigator or sub-investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TCR repertoire analysis, identification of MHC-restricted antigens, methylome analysis, phosphorylation signaling pathway analysis, multi-color TIL analysis of tumor tissues, and single cell analysis of fresh tumor tissues will be performed using various peripheral immune cell fractions and collected tissues to analyze in detail the immunological significance of each immune cell cluster.
- Secondary Outcome Measures
Name Time Method (1) To analyze the relationship between various clinical outcomes (ORR, PFS, OS, etc.) and peripheral blood biomarkers (discrimination formula* below). * In PBMC, the discrimination formula is X2/Y, where X is the ratio of CD62Llow cells to CD4+ T cells and Y is the ratio of CD25+Foxp3+ cells. 2) Analyze the relationship between the various clinical outcomes and the newly identified peripheral immune cell subclusters and the expression of checkpoint molecules expressed on them.