Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621095
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer ALTER-PA-001
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer a Prospective Randomized Controlled Clinical Trial ALTER-PA-001
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG nab-paclitaxel and gemcitabine as first-line treatment compared with AG nab-paclitaxel and gemcitabine in metastatic pancreatic cancer
Detailed Description:
This is an open-label multicenter randomized controlled clinical trial We plan to recruit 104 subjects and randomly assign them in a 21 ratio to either the experimental group receiving Anlotinib plus Benmelstobart plus Gemcitabine and Nab-Paclitaxel or the control group receiving Gemcitabine and Nab-Paclitaxel as initial treatment Each cycle of the aforementioned drugs will last three weeks with tumor efficacy assessments conducted at the end of cycles 2 4 6 and 8 After 8 cycles of treatment patients in the experimental group who achieve complete response CR partial response PR or stable disease SD will continue with maintenance therapy using Anlotinib plus Benmelstobart plus Gemcitabine Similarly after 8 cycles of treatment patients in the control group who achieve CR PR or SD will continue with maintenance therapy using Gemcitabine monotherapy Efficacy will be evaluated every 3 cycles 9 weeks during the maintenance phase until disease progression or intolerability This study aims to evaluate the efficacy and safety of the combination of Anlotinib and Benmelstobart with Gemcitabine and Nab-Paclitaxel in treating metastatic pancreatic cancer providing a new treatment option for first-line therapy in patients with advanced metastatic pancreatic cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None