Study of Adjuvant ONO-4538 With Resected Gastric Cancer

  • STATUS
    Recruiting
  • participants needed
    700
  • sponsor
    Ono Pharmaceutical Co. Ltd
Updated on 25 January 2021
gastrectomy
carcinoma
oxaliplatin
gastric adenocarcinoma
lymphadenectomy
capecitabine
gastric carcinoma
cancer chemotherapy
adenocarcinoma
adjuvant chemotherapy
tegafur
immunostimulants
gimeracil

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.

Details
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

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Gastropathy or Stomach Cancer or Gastric Cancer or Stomach Discomfort?
Do you have any of these conditions: Gastropathy or Gastric Carcinoma or Stomach Cancer or Gastric Cancer or Stomach Discomfort or gastric cancers?
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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