Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.

Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer. - To Investigate Marker of adverse events and therapeutic effects of immune-checkpoint inhibitors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025834

Enrollment

Registered

2017-01-24

Start date

2017-01-24

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) Age of more than 20 years old . (2) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) HBs antigen, HCV antibody, HIV antibody are positive. (2) An inappropriate case judged by doctor in charge.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Japan

Contacts

Public ContactKazuyuki HAMADA

Showa University School of Medicine Department of Internal Medicine,Division of Medical Oncology

hamadakaz@med.showa-u.ac.jp03-3784-8402

Outcome results