Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492941
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-24
Brief Title:
A Study of Docetaxel for Injection Albumin Bound in Patients With Advanced Pancreatic Cancer
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Organization:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Multicenter Phase Ⅲ Clinical Study of Docetaxel for Injection Albumin Bound Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 study is a randomized double-blind multicenter phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection Albumin Bound in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens
Detailed Description:
This study is a randomized double-blind multicenter phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection Albumin bound plus best supportive care versus placebo plus best supportive care in participants with pancreatic cancer who have received a previous treatment regimen containing gemcitabine and fluorouracil It is planned to enroll 142 participants and participants will be randomized to receive Docetaxel for Injection albumin bound in combination with best supportive care or placebo in combination with best supportive care in a 21 ratio Best supportive care includes but is not limited to pain control nutritional support and psychological care
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