Unresectable advanced or recurrent gastric or esophagogastric junction cancer
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed unresectable or recurrent gastric or esophago-gastric junction adenocarcinoma 2) HER2 negative 3) Planned to receive nivolumab plus chemotherapy 4) No prior systemic anticancer therapy for advanced or metastatic disease 5) Eastern Cooperative Oncology Group (ECOG)Performance status of 0-2 6) Life expectancy of at least 3 months 7) Evaluable lesions based on CT or MRI within 30 days prior to registration 8) Available tumor specimens for biomarker analysis 9) Without severe organ dysfunction confirmed by laboratory test within 30 days prior to registration
Exclusion criteria
Exclusion criteria: 1) Concomitant active malignancies within 3 years prior to registration 2) Active autoimmune disease 3) Requiring systemic corticosteroid or immunosuppressant within 14 days prior to registration 4) Active infection under treatment 5) Pregnant or lactating female 6) Uncontrolled psychiatry disease 7) History of serious allergic reactions 8) Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Time to Treatment Failure, Overall Response Rate, Duration of Response, Disease Control Rate, Safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed