Gastric Cancer
Conditions
Keywords
ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Brief summary
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.
Interventions
DRUGNivolumab
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
DRUGOxaliplatin
Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
DRUGCapecitabine
Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
DRUGPlacebo
Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Sponsors
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed adenocarcinoma of the stomach * Patients without a remnant cancer (R0) who have undergone gastrectomy * Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
Exclusion criteria
* Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer * Multiple primary cancers * A current or past history of severe hypersensitivity to any other antibody products * Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 3-year OS rate | 3 years |
| 5-year OS rate | 5 years |
| 3-year RFS rate | 3 years |
| Overall survival (OS) | 5 years |
| Safety will be analyzed through the incidence of adverse events, serious adverse events | Up to 28 days from last dose |
| Safety will be analyzed through the incidence of laboratory abnormalities | Up to 28 days from last dose |
| 5-year RFS rate | 5 years |
Countries
China, Japan, South Korea, Taiwan
Outcome results
None listed