Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-07 @ 1:27 PM
Study NCT ID:
NCT05669092
Status:
RECRUITING
Last Update Posted:
2022-12-30
First Post:
2022-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status
Sponsor:
Zhejiang Cancer Hospital
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Open-label, Multicenter, Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status(APRAM)
Status:
RECRUITING
Status Verified Date:
2022-12
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:
pMMR/MSS and 32 dMMR/MSI-H patientspatients were planned to be enrolled. Patients with dMMR/MSI-H will be randomly assigned to the immunotherapy arm or short-course radiotherapy sequential immunotherapy arm; pMMR/MSS patients will receive capecitabine-irinotecan based concurrent radiotherapy before being randomly assigned to the XELIRI or FOLFRINOX arm.
The rate of complete response (sustained cCR for ≥ 1 year), long-term prognosis and adverse effects will be analyzed.
The rate of complete response (sustained cCR for ≥ 1 year), long-term prognosis and adverse effects will be analyzed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: