Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04136600
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2019-10-19
Brief Title:
EGFR Monoclonal Antibody for Advanced Gastric Cancer
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
A Study of EGFR Monoclonal Antibody CetuximabNimotuzumab in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With EGFR-amplification Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody CetuximabNimotuzumab in combination with a chemotherapy in gastric cancer patients with EGFR amplification
Detailed Description:
This parallel randomized open-label single-centre study will evaluate the effect on overall survival of EGFR monoclonal antibody CetuximabNimotuzumab in combination with a chemotherapy compared to the chemotherapy alone in patients with EGFR-amplication advanced gastric cancer Cetuximab will be administered as intravenous infusion of 500 mgm2 BSA every 3 weeks while nimotuzumab will be administered as intravenous infusion of 400mg every week The chemotherapy consists of a combination of 12 cycles of mFOLFOX-6 6-8 cycles of SOX 6-8 cycles of CapOX Treatment with cetuximabnimotuzumab will continue until disease progression The target sample size is 50-100 patients
Study Oversight
Has Oversight DMC:
None
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?:
None