Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304987
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-05
Brief Title:
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMRMSS Locally Advanced Mid-low Rectal Cancer
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
The Efficacy and Safety of Preoperative Neoadjuvant Chemoradiation Combined With PD-1 Inhibitor and PCSK9 Inhibitor in the Treatment of pMMRMSS Locally Advanced Middle and Low Rectal Cancer a Multicenter Study Prospective Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 a multicenter prospective randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMRMSS locally advanced middle and low rectal cancer
Detailed Description:
This study included patients with locally advanced low rectal cancer as research subjects and evaluated the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor Sintilimab and PCSK9 inhibitor Tafolecimab or neoadjuvant chemoradiotherapy combined with PD -1 Sintilimab for patients with locally advanced rectal cancer The primary endpoints of the study are clinical complete response cCR including imaging and endoscopic complete response and pathological complete response pCR Secondary endpoints are major pathological response rate MPR objective response rate ORR disease-free survival DFS overall survival OS organ preservation rate OPR and neoadjuvant rectal NAR score quality of life score QoL safety and tolerability
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