For Healthcare Professionals

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:

  1. Patients with histologically confirmed adenocarcinoma of the stomach
  2. Patients without a remnant cancer (R0) who have undergone gastrectomy
  3. Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1


Exclusion Criteria:

  1. Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
  2. Multiple primary cancers
  3. A current or past history of severe hypersensitivity to any other antibody products
  4. Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

pin location

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


Gastric Cancer

Age (in years)

20 - 80


Phase 3

Participants needed


Est. Completion Date

Mar 31, 2024

Treatment type



Ono Pharmaceutical Co. Ltd identifier


Study number


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