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Study of Adjuvant ONO-4538 With Resected Gastric Cancer

NCT03006705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-05-03

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-08-17
Completion
2023-03-31

Countries

  • China
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03006705 on ClinicalTrials.gov