Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:49 AM
Study NCT ID:
NCT05616494
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-arm, Multicenter, Phase Ⅱ Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer Who Have Received at Least One Line of Therapy
Status:
UNKNOWN
Status Verified Date:
2022-10
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 trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) in patients with pancreatic cancer.
Detailed Description:
Simon two-stage design will be adopted in this study. In the first stage, 24 patients will be enrolled, if at least 2 of them get response (CR or PR), the second stage of the study will be conducted, and 29 additional patients will be enrolled. If there is only one or no patients get response (CR or PR) in the first stage, the study will be early terminated.
Study Oversight
Has Oversight DMC:
False
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?: