Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390982
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer RELIEVE -01 Study
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Single-arm Multicenter Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancerthe RELIEVE-01 Study
Status:
NOT_YET_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:
This is an open-label multi-center single-arm clinical study All patients received concurrent chemoradiation therapy CRT followed by 4 cycles of tislelizumab combined with CAPOX then underwent clinical response assessment Patients who achieved CR cCR pCR confirmed by local resection of ncCR continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles then Watch and Wait Patients who did not achieved CR underwent total mesorectal excision TME
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