Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493240
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-02
Brief Title:
Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
Status:
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:
NLCCRIT-LARC
Brief Summary:
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab PD-1 inhibitor in patients with locally advanced rectal cancer
Detailed Description:
Investigator designed a single-arm open-label phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab PD-1 inhibitor for locally advanced rectal cancerParticipants will accept capecitabine-based long-term radiotherapy504Gy radiation followed by 200mg Sintilimab each time for 3 times with 2-week intervals The primary endpoint is pCR rate and secondary endpoints include sphincter-preserving rate adverse event rates
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Z220014 | OTHER_GRANT | None | None |