Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426654
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMRMSI-H Gastric Cancer
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch RepairMicrosatellite Instability-high Gastric Cancer a Prospective Multi-center Single-arm Phase IbII Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Recently growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient dMMRmicrosatellite instability-high MSI-H gastric cancer In this study we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMRMSI-H GGEJ cancer
Detailed Description:
This is a prospective multicenter single-arm phase IbII trial In the phase Ib 4 cases will be enrolled in each treatment group In the phase II study a total of 33 patients will be enrolled Eligible patients will be registered and receive four cycles of sintilimab Simultaneously LDRT will be planned and administered Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab The primary endpoint of phase Ib is to determine the optimal radiation dose for phase II study The primary endpoint of phase II is the pathological complete response pCR rate Secondary endpoints include R0 resection rate major pathological response MPR objective response rate ORR 3-year event-free survival EFS rate 3-year overall survival OS rate and safety profile of the neoadjuvant regimen
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