Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507371
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer An Randomized Prospective Multicenter Open-label Phase III Clinical Trial mRCAT-III
Status:
RECRUITING
Status Verified Date:
2024-07
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:
mRCAT-III
Brief Summary:
This is a randomized prospective multicenter open-label Phase III clinical trial to evaluate node-sparing modified short-course radiation Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes combined with CAPOX and PD-1 Inhibitor Tislelizumab compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer A total of 170 patients will be enrolled in this trial The primary endpoint is the rate of pathological complete response pCR The EFS rate ORR organ preservation rate long-term prognosis and adverse effects will also be analyzed
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