The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
493
Overall survival
Time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Progression-free survival
Time frame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Objective response rate
Time frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Duration of response
Time frame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Continuously throughout study treatment and up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Continuously throughout study treatment and up to 28 days from last dose
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Aichi Clinical Site
Nagoya, Aichi-ken, Japan
Aomori Clinical Site
Misawa, Aomori, Japan
Ehime Clinical Site
Matsuyama, Ehime, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan
Hyogo Clinical Site
Akashi, Hyōgo, Japan
Hyogo Clinical Site
Kobe, Hyōgo, Japan
Ishikawa Clinical Site
Kanazawa, Ishikawa-ken, Japan
Kanagawa Clinical Site
Kawasaki, Kanagawa, Japan
Kanagawa Clinical Site
Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
...and 39 more locations