the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

Recruiting

• Conditions: Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy

• Registration Number: NCT06378840
• Lead Sponsor: RenJi Hospital

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 Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy	1 year	the investigators will focus on the occurrence and grade of side effect from immunotherapy according to the NCCN clinical practice guidelines in the evaluation and management of immunotherapy-related toxicity (through the symptoms, physical examination, and also through blood/image/endoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes concentration, EKG, echocardiography, CT/MRI, et al). And through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular to a possible biomarker of the occurrence of any immunotherapy-related side effect.
the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy	2 years	through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular to a possible biomarker of disease control (disease progression or not accordingly to the RECIST criterion)
the change of immune cells in the blood after chemoradiotherapy and immunotherapy	1 year	through single-cell sequence and data analysis, the investigators will focus on the percentage of each sub-type of immune cells after treatment, differential gene expression profiles in special cell type after chemoradiotherapy and immunotherapy.

Secondary Outcome Measures

Name	Time	Method
the change of immune cells in the tissue after chemoradiotherapy	1 year	through single-cell sequence and data analysis, the investigators will focus on the percentage of each sub-type of immune cells in the tumor microenvironment and differential gene expression profiles in special cell type after chemoradiotherapy.
the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy	2 years	through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular in the tumor tissue to a possible biomarker of disease control (disease progression or not accordingly to the RECIST criterion)
the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy	1 year	through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular in the tumor tissue to a possible biomarker of the occurrence of any immunotherapy-related side effect.

Trial Locations

Locations (1)

RenJi hospital; 🇨🇳 Shanghai, China