Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04906044
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-05-10
Brief Title:
Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer STARS-RC03
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
STARS-RC03
Brief Summary:
There have been many high-quality research publications including the TNT model of short-term radiotherapy combined with consolidation chemotherapy and the TNT model of three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined with CRT All have achieved better tumor regression and tumor regression than the standard CRT model The higher pCR rate reduces the recurrence and metastasis events improves the prognosis and strives for more opportunities for organ function preservation Can the TNT model combined with immunotherapy further increase the cCR rate Whether immunotherapy can bring further survival benefits to patients who develop CR after neoadjuvant therapy especially WW after cCR it is also necessary to carry out corresponding clinical research We designed this study for patients with mid-to-low and locally advanced rectal cancer who want to be able to preserve the anus TNT mode combined with PD-1 immunotherapy is given before surgery and TME surgery is performed on patients who have not reached cCR or who still require surgery It provides sufficient evidence for the safety and effectiveness of preoperative neoadjuvant therapy for PD-1 in low- and middle-level locally advanced rectal cancer
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