Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496373
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-18
Brief Title:
Clinical Study of XP-004 Personalized mRNA Tumor Vaccine Combined With PD-1 Inhibitor for Postoperative Adjuvant Therapy for Pancreatic Cancer in Patients With Advanced Solid Tumors
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Clinical Study of XP-004 Personalized mRNA Tumor Vaccine Combined With PD-1 Inhibitor for Postoperative Adjuvant Therapy for Pancreatic Cancer in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The main purpose of this study is to observe and evaluate the safety and tolerance of XP-004 personalized mRNA vaccine encoding tumor neoantigen combined with PD-1 inhibitor for adjuvant treatment of patients who cannot tolerate chemotherapy after radical resection of pancreatic cancer
The secondary objective was to observe the initial efficacy of adjuvant therapy with XP-004 personalized mRNA vaccine combined with PD-1 inhibitor in patients with pancreatic cancer after radical surgery by the indicators of XP-004 personalized mRNA vaccine induced activstion of Antigen specific CD4 and CD8 T cells Recurrence free survival RFS and Overall Survival OS
The secondary objective was to observe the initial efficacy of adjuvant therapy with XP-004 personalized mRNA vaccine combined with PD-1 inhibitor in patients with pancreatic cancer after radical surgery by the indicators of XP-004 personalized mRNA vaccine induced activstion of Antigen specific CD4 and CD8 T cells Recurrence free survival RFS and Overall Survival OS
Detailed Description:
None
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