Gastric Cancer
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Scheduled to receive nivolumab monotherapy 2) Histologically confirmed adenocarcinoma of the stomach or esophago-gastric junction 3) Available tumor specimens for biomarker analysis 4) Having evaluable lesions based on CT imaging within 28 days prior to registration 5) Patents treated with at least two or more lines of previous chemotherapy 6) No prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells 7) No systemic corticosteroids (10 mg/day or more) or immune-suppressants administered concurrently or within 14 days before registration
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous malignancies 2) A positive test result for any of the followings: Human immunodeficiency virus antibody, hepatitis B surfaces (HBs) antigen, or hepatitis C virus antibody 3) Positive test result for either HBs antibody or hepatitis B core antibody, with a detectable level of hepatitis B virus-deoxyribonucleic acid (HBV-DNA) even in case of negative HBs antigen test 4) Judged to be incapable of providing consent for certain reasons, such as concurrent dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the factors related of efficacy of nivolumab such as response, progression free survival and overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore the mechanism of intrinsic and acquired resistance of nivolumab | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed