Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550453
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Safety and Efficacy of Pembrolizumab in Combination With Bevacizumab CapeOX in the Neoadjuvant Treatment of RAS-mutated BRAF Wild-type Microsatellite-stabilized Locally Advanced Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Pembrolizumab in Combination With Bevacizumab CapeOX in the Neoadjuvant Treatment of RAS-mutated BRAF Wild-type Microsatellite-stabilized Locally Advanced Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated BRAF wild-type microsatellite-stabilized locally advanced colorectal cancer
Methods and analysis A prospective open-label single-arm phase 2 clinical study protocol will enroll a total of 20 patients The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer LACRC patients Initially 9 patients will be recruited in the Simon I phase and if more than 1 patient achieves a pathological complete response pCR the study will proceed to the II phase Recruit up to 20 patients in Phase II and if more than 4 patients achieve pCR the trial will be considered successful All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab bevacizumab and CapeOX bevacizumab oxaliplatin capecitabine The primary efficacy endpoint is the pathological complete response pCR of the cancer following neoadjuvant therapy Secondary efficacy endpoints include major pathological response MPR objective response rate ORR and assessment of adverse events AEs
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital Xijing HospitalKY20232402-F-1
Methods and analysis A prospective open-label single-arm phase 2 clinical study protocol will enroll a total of 20 patients The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer LACRC patients Initially 9 patients will be recruited in the Simon I phase and if more than 1 patient achieves a pathological complete response pCR the study will proceed to the II phase Recruit up to 20 patients in Phase II and if more than 4 patients achieve pCR the trial will be considered successful All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab bevacizumab and CapeOX bevacizumab oxaliplatin capecitabine The primary efficacy endpoint is the pathological complete response pCR of the cancer following neoadjuvant therapy Secondary efficacy endpoints include major pathological response MPR objective response rate ORR and assessment of adverse events AEs
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital Xijing HospitalKY20232402-F-1
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