Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT03006705
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
  • Tegafur-gimeracil-oteracil potassium — DRUG
    Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
  • Capecitabine — DRUG
    Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
  • Placebo — DRUG
    Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
May 2024
Primary completion
Aug 17, 2022
Completion
Mar 31, 2023

Study Design

Enrollment
800 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab group
    Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
  • Placebo Comparator: Placebo group
    Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: 5 years ]

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