Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT03006705
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Sponsor:
Ono Pharmaceutical Co. Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: