Advanced gastric or esophago-gastric junction MSI-H tumor.
Conditions
Sponsors
Hisato Kawakami (Coordinating Investigator)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must have histologically confirmed adenocarcinoma of gastric or esophago-gastric junction. 2.Subject must have unresectable advanced, recurrent or metastatic gastric or esophago-gastric junction adenocarcinoma. 3.Subjects must have confirmed MSI-H. 4.Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery. 5.No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease. 6.ECOG performance status of 0 or 1..
Exclusion criteria
Exclusion criteria: 1.Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before enrollment. 2.Subjects who received radiation therapy for local control or pain control within 14 days prior to enrollment. 3.Subjects who received blood transfusion or hematopoietics within 14 days prior to enrollment. 4.Other prior malignancy requiring active treatment within the previous 3 years from enrollment .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy ORR (Central assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy other ORR (Investigator assessment) Disease Control Rate(CR+PR+SD)(Central and Investigator assessments) PFS((Central and Investigator assessments) OS DoR(Central and Investigator assessments) Time to response(Central and Investigator assessments) safety and tolerability concordance rate of MSI-H between assays. To explore potential biomarkers associated with clinical efficacy (ORR, PFS, OS) and/or with incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKen Mizushima
Ken Mizushima
Outcome results
None listed