Study of Adjuvant ONO-4538 With Resected Gastric Cancer
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Gastric Cancer
Age (in years)
20 - 80
Phase
Phase 3
Participants needed
800
Est. Completion Date
Mar 31, 2024
Treatment type
Interventional
Sponsor
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov identifier
NCT03006705
Study number
ONO-4538-38
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