Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378840
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-10
Brief Title:
the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
An Exploratory Analysis of the Predictive Value of Immune Cell Using Single-cell Sequencing on the Outcome of Locally Advanced Cervical Cancer Treated by Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor
Status:
RECRUITING
Status Verified Date:
2024-04
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:
To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor
Detailed Description:
Concurrent chemoradiotherapy is the standard treatment for patients with locally advanced cervical cancer but the treatment failure rate is up to 40 in previous studies Immunotherapy using PD-1 inhibitor showed an objective response rate of 12-50 in studies and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy And according to KEYNOTE-A18 the addition of PD-1 inhibitor Pembrolizumab to the current concurrent chemoradiotherapy improved the PFS of such group of patients But the detailed change of immune cells tumor microenvironment and PBMC during treatment is unknown and studies on the relationship between immune cells and treatment-related side effect and efficiency is also in need
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None