Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396637
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-30
Brief Title:
PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment
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 prognosis for pancreatic cancer remains dismal with current guidelines favoring FOLFIRINOX or AG consisting of Gemcitabine and Abraxane as the primary chemotherapeutic option However research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies In this context researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment
Detailed Description:
There is no standard treatment for patients with metastatic pancreatic cancer who failed to FOLFIRINOX or AG consisting of Gemcitabine and Abraxane Patients with metastatic pancreatic cancer who are unable to tolerate or have failed to respond to standard chemotherapy will be enrolled in this clinical trial They will be administered a combination treatment of Sapropterin Dihydrochloride and PD-1 antibody The primary endpoints of this study are objective response rate and safety The secondary endpoints will encompass overall survival progression-free survival and quality of life The study aims to enroll a total of 20 participants
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