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Completed

NCT Number: NCT03006705

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Province Clinical Site, Anhui Province, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

Other names: BMS-936558, ONO-4538, MDX-1106

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).

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: 5 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

  2. 3-year OS rate

    Time frame: 3 years

  3. 5-year OS rate

    Time frame: 5 years

  4. 3-year RFS rate

    Time frame: 3 years

  5. 5-year RFS rate

    Time frame: 5 years

  6. Safety will be analyzed through the incidence of adverse events, serious adverse events

    Time frame: Up to 28 days from last dose

  7. Safety will be analyzed through the incidence of laboratory abnormalities

    Time frame: Up to 28 days from last dose

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Dec 30, 2016
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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