Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-01 @ 12:33 AM
Study NCT ID:
NCT06621095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)
Sponsor:
RenJi Hospital
Organization:
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:
False
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 2:1 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:
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?: