Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389760
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-11
Brief Title:
Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer a Prospective Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2023-08
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:
This is a prospective multicenter single-arm phase II trial The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer
Detailed Description:
This clinical study is designed as a prospective multicenter open-label single arm phase II study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX as postoperative adjuvant therapy in pancreatic cancer The main endpoint is disease-free survival DFS Additional end points included distant metastasis-free survival DMFS overall survival OS quality of life tumor-related markers and safety
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