The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
800
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
Relapse-free survival (RFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
3-year OS rate
Time frame: 3 years
5-year OS rate
Time frame: 5 years
3-year RFS rate
Time frame: 3 years
5-year RFS rate
Time frame: 5 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Up to 28 days from last dose
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Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Anhui Province Clinical Site
Anhui Province, China
Beijing Clinical Site1
Beijing, China
Beijing Clinical Site2
Beijing, China
Cuangdong Province Clinical Site
Cuangdong Province, China
Guangdong Province Clinical Site1
Guangdong Province, China
Guangdong Province Clinical Site2
Guangdong Province, China
Henan Province Clinical Site1
Henan Province, China
Henan Province Clinical Site2
Henan Province, China
Jiangsu Province Clinical Site1
Jiangsu Province, China
Jiangsu Province Clinical Site3
Jiangsu Province, China
...and 98 more locations