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RecruitingNCT06378840

the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

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
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
RenJi Hospital · Academic / Other
Sex
Female
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONNab-paclitaxel/Platinum, SintilimabSintilimab Combined With Concurrent Nab-paclitaxel/Platinum-based Chemoradiotherapy

Timeline

Start date
2022-01-01
Primary completion
2024-12-30
Completion
2024-12-30
First posted
2024-04-23
Last updated
2024-04-23

Locations

1 site across 1 country: China

Regulatory

Source: ClinicalTrials.gov record NCT06378840. Inclusion in this directory is not an endorsement.