Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409429
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Prospective Multicenter Randomized Double-blind Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Status:
NOT_YET_RECRUITING
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:
This is a prospective multicenter randomized double-blind placebo-controlled study The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer
Detailed Description:
This clinical study is designed as a prospective multicenter randomized double-blind placebo-controlled study to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX gemcitabine plus capecitabine compared with GX only for resected pancreatic cancer About 146 patients will be enrolled in this study and randomly divided into experimental group nimotuzumab plus GX and control group placebo plus GX at a ratio of 11 The main endpoint is relapse-free survival RFS Additional end points included distant metastasis-free survival DMFS overall survival OS 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