Study of Adjuvant ONO-4538 With Resected Gastric Cancer

  • participants needed
  • sponsor
    Ono Pharmaceutical Co. Ltd
Updated on 25 January 2021
gastric adenocarcinoma
gastric carcinoma
cancer chemotherapy
adjuvant chemotherapy


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.

Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine, Placebo, Oxaliplatin, Nivolumab, tegafur-gimeracil-oteracil potassium
Clinical Study IdentifierNCT03006705
SponsorOno Pharmaceutical Co. Ltd
Last Modified on25 January 2021


Yes No Not Sure

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
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