Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520683
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Adjuvant PD-1 Blockade for High-risk Stage-II dMMRMSI-H Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short-course PD-1 Blockade as Adjuvant Treatment for High-risk Stage-II dMMRMSI-H Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SMALLER
Brief Summary:
This open-label phase III trial investigates the efficacy of two cycles of PD-1 blockade Tislelizumab as adjuvant therapy to see how it works compared with standard of care SOC in treating patients with stage II dMMRMSI-H colorectal cancer
The rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy which suggests that PD-1 blockade may likely improve patients long-term survival
As for the short course two cycles we have the following considerations firstly the NICHE-2 trial which adopted a two-cycle regimen reported no recurrences during follow-up suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMRMSI-H colorectal cancer Secondly the potential benefits of PD-1 blockade should be balanced against its toxicities because patients with stage-II dMMR colorectal cancer generally have a good prognosis Two cycles of PD-1 blockade have been shown to have a good safety profile with low incidence of grade 3-4 and immune-related adverse events
The rational of giving PD-1 blockade as adjuvant therapy is based on the fact that tumor recurrence is extremely low among patients receiving neoadjuvant immunotherapy which suggests that PD-1 blockade may likely improve patients long-term survival
As for the short course two cycles we have the following considerations firstly the NICHE-2 trial which adopted a two-cycle regimen reported no recurrences during follow-up suggesting that short-course anti-PD-1 therapy may be sufficient to improve the survival of patients with localized dMMRMSI-H colorectal cancer Secondly the potential benefits of PD-1 blockade should be balanced against its toxicities because patients with stage-II dMMR colorectal cancer generally have a good prognosis Two cycles of PD-1 blockade have been shown to have a good safety profile with low incidence of grade 3-4 and immune-related adverse events
Detailed Description:
This is an open-label multi-centre randomised phase III trial comparing the combination of PD-1 blockade SOC versus SOC alone as adjuvant therapy for patients with high-risk stage-II dMMRMSI-H colorectal cancer
Primary Objective To determine whether the addition of Tislelizumab can significantly improve disease-free survival DFS compared to standard of care in patients with high-risk stage-II colorectal cancer
Secondary objectives
To determine whether the addition of Tislelizumab can significantly improve overall survival OS compared to standard of care
To assess the adverse events AE profile including immune-related adverse events ir-AEs
OUTLINE Patients are randomized to 1 of 2 arms stratified by cT4 status
Arm 1 experimental group patients receive Tislelizumab 200mg intravenously on day 1 with or without adjuvant chemotherapy and repeat the treatment on day 22 Patients undergo routine follow-up every 3 months for the first 3 years and then every 6 months for the year 4-5
Arm 2 control group patients receive standard of care SOC whether with surveillance alone single-agent Capecitabine or CapeOxFOLFOX at the discretion of the doctor in charge Patients undergo routine follow-up every 3 months for the first 3 years and then every 6 months for the year 4-5
Statistics According to the statistical design 180 patients 90 per arm are to be randomized The study is expected to take up to 36 months to complete accrual
Primary Objective To determine whether the addition of Tislelizumab can significantly improve disease-free survival DFS compared to standard of care in patients with high-risk stage-II colorectal cancer
Secondary objectives
To determine whether the addition of Tislelizumab can significantly improve overall survival OS compared to standard of care
To assess the adverse events AE profile including immune-related adverse events ir-AEs
OUTLINE Patients are randomized to 1 of 2 arms stratified by cT4 status
Arm 1 experimental group patients receive Tislelizumab 200mg intravenously on day 1 with or without adjuvant chemotherapy and repeat the treatment on day 22 Patients undergo routine follow-up every 3 months for the first 3 years and then every 6 months for the year 4-5
Arm 2 control group patients receive standard of care SOC whether with surveillance alone single-agent Capecitabine or CapeOxFOLFOX at the discretion of the doctor in charge Patients undergo routine follow-up every 3 months for the first 3 years and then every 6 months for the year 4-5
Statistics According to the statistical design 180 patients 90 per arm are to be randomized The study is expected to take up to 36 months to complete accrual
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