NCT03006705

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

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

Timeline

• Start date: 2017-01-31
• Primary completion: 2022-08-17
• Completion: 2023-03-31
• First posted: 2016-12-30
• Last updated: 2024-05-03

Locations

108 sites across 4 countries: China, Japan, South Korea, Taiwan