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)

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) - 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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044536

Enrollment

300

Registered

2021-06-14

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant tumors

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients aged 20 years or older at the time of obtaining consent (2) Patients who have been fully informed of the contents of this study and have given their written consent. 3) PS0-2 4) Patients with an estimated prognosis of at least 3 months 5) Patients with evaluable lesions (measurable lesions are not required) Additional criteria will be added for each type of carcinoma.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Countries

Japan

Contacts

Public ContactAtsuto Mouri

Saitama Medical University International Medical Center Department of Respiratory Medicine

mouria@saitama-med.ac.jp0429844111

Outcome results