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.

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. - Pharmacodynamic analysis and the mechanism of immune-related adverse events in immune-checkpoint inhibitor.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025796

Enrollment

Registered

2017-01-22

Start date

2017-01-22

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

solid cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) ECOG performance status (PS) of 0 to 2. (2) Age of more than 20 years old. (3) Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactKazuyuki Hamada

Showa University Department of Internal Medicine,Division of Medical Oncology

hamadakaz@med.showa-u.ac.jp03-3784-8000

Outcome results