Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613165
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer a ProspectiveMulticentre Single-arm Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer a ProspectiveMulticentre Single-arm Study
Status:
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 aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum under the premise of ensuring pathological complete response pCR among patients with dMMRMSI-H rectal cancer
Participants will receive preoperative monotherapy with PD-1 antibodies with regular reassessments every 2 cycles Surgical intervention will be performed if clinical complete response cCR is achieved
Researchers will compare the pathological complete response rates adverse reactions and three-year event-free survival rates across different treatment cycles
Participants will receive preoperative monotherapy with PD-1 antibodies with regular reassessments every 2 cycles Surgical intervention will be performed if clinical complete response cCR is achieved
Researchers will compare the pathological complete response rates adverse reactions and three-year event-free survival rates across different treatment cycles
Detailed Description:
None
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