unresectable advanced gastric cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed gastric or esophago-gastric junction adenocarcinoma 2)Unresectable locally advanced or metastatic adenocarcinoma of the stomach or esophago-gastric junction 3)Eastern Cooperative Oncology Group (ECOG)Performance status of 0 or 1 4)Having evaluable disease 5)No prior systemic anticancer therapy for advanced or metastatic disease. For recurrent gastric cancer patients, the last administration of prior adjuvant or neoadjuvant chemotherapy was done at least 24 weeks before enrollment. 6)Adequate organ function 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Having concomitant active malignancies. 2)Requiring systemic corticosteroid or immunosuppressant. 3)History of prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody which specifically targets T-cell co-stimulation or checkpoint pathways. 4)Inappropriate judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with MSI-high in chemotherapy-naive gastric cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinicopathological features of advanced or recurrent gastric cancer with MSI-high status 2) Turn-around-time of MSI test 3) Success rate of MSI test | — |
Countries
Japan
Contacts
West Japan Oncology Group WJOG datacenter