Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-01-13
Brief Title:
PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMRMSI-H Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
PD-1 Inhibitors Camrelizumab Combined With VEGF Inhibitors Apatinib for Locally Advanced dMMRMSI-H Colorectal Cancer an Open-label Multi-center Phase II Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
In this open-label phase II study patients will be scheduled for neoadjuvant treatment with PD-1 inhibitors Camrelizumab plus VEGF inhibitor Apatinib for dMMRMSI-H colorectal cancer staged as locally advanced cT3-4N-M0 for rectal cancer cT4 or cT3 with extramural extension 5mm for colon cancer Radiological evaluation will be preformed after 4 cycles of treatment Patients either with colon or rectal cancer who achieve complete clinical response will be offered the choice of Watch Wait
Detailed Description:
This is an open-label phase II study with the aim of determining the efficacy of PD-1 inhibitors Camrelizumab plus VEGF inhibitor Apatinib as a neoadjuvant therapy for dMMRMSI-H locally advanced colorectal cancer
Patients will be evaluated for eligibility within 14 days prior to study initiation with CT for colon cancer andor MRI for rectal cancer
Patients will be given four cycles of Camrelizumab 200mg iv every 3 weeks plus Apatinib 250mg QD day1-14 before being evaluated for response For patients with colon cancer if a SDPD is achieved and the tumor is deemed unresectable they will be offered chemotherapyradiotherapy while if a CR or PR is achieved they will be offered another four cycles of Camrelizumab Apatinib After completing 8 cycles of treatment if a CR is achieved they will be offered the choice of Watch Wait For patients with rectal cancer who have a SDPD after 4 cycles chemoradiotherapy will be offered while for those with a CRPR another four cycles of the treatment will be given After completing 8 cycles of treatment if a CR is achieved patients will be offered the choice of Watch Wait
Patients will be evaluated for eligibility within 14 days prior to study initiation with CT for colon cancer andor MRI for rectal cancer
Patients will be given four cycles of Camrelizumab 200mg iv every 3 weeks plus Apatinib 250mg QD day1-14 before being evaluated for response For patients with colon cancer if a SDPD is achieved and the tumor is deemed unresectable they will be offered chemotherapyradiotherapy while if a CR or PR is achieved they will be offered another four cycles of Camrelizumab Apatinib After completing 8 cycles of treatment if a CR is achieved they will be offered the choice of Watch Wait For patients with rectal cancer who have a SDPD after 4 cycles chemoradiotherapy will be offered while for those with a CRPR another four cycles of the treatment will be given After completing 8 cycles of treatment if a CR is achieved patients will be offered the choice of Watch Wait
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