Gastric cancer
Conditions
Interventions
None listed
Sponsors
Keio University Hospital Department of Internal Medicine, Division of Gastroenterology and Hepatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 years or older at the time of registration. 2) Advanced unresectable or recurrent gastric cancer (including junctional cancer) with histologically confirmed adenocarcinoma. (3) ECOG performance status 0 to 2. (4) Patients must be planned to treat with anti-PD-1 antibody (any line of treatment is acceptable). 5) Patients must have evaluable lesions on contrast-enhanced CT/MRI within 28 days prior to enrollment (measurable lesions are not required). *Simple CT/MRI is acceptable if CT contrast agent is difficult to use due to contrast agent allergy or renal dysfunction. 6) Availability of fasting blood samples for biomarker research. 7) No prior therapy with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, or other T-cell modulating drugs prior to enrollment. 8) No systemic corticosteroids equivalent to prednisolone exceeding 10 mg/day (except for temporary use for testing or prophylactic administration) or immunosuppressive agents within 14 days prior to enrollment. 9) Written consent for participation in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: (1) Patients with active multiple cancers (concurrent multiple cancers/multiple cancers and heterogeneous multiple cancers/multiple cancers with disease-free interval of 3 years or less. (However, if the cancer is not a prognostic factor for the patient, it is not excluded.) (2) Patients with psychosis or psychiatric symptoms that interfere with daily life, making it difficult to participate in the study. 3) Other conditions deemed inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| none | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between metabolite (amino acids and lipid metabolites etc.),and cytokines in blood samples before treatment and 1)Progression free survival, overall survival, and response rate of anti-PD-1 antibody and its subsequent chemotherapy, 2)immune related adverse event Correlation between each biomarker. | — |
Countries
Japan
Contacts
Public ContactKai Tsugaru
Keio University Hospital Department of Internal Medicine, Division of Gastroenterology and Hepatology
Outcome results
None listed