Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma

Active, not recruiting

• Conditions: Histopathological Diagnosis of Nasopharyngeal Carcinoma; Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition

• Registration Number: NCT06762470
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

Brief Summary

In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte CD4/CD8 ratio in nasopharyngeal carcinoma patients prior to treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Study Start: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• 1.Histopathological diagnosis of nasopharyngeal carcinoma;2.Patients with nasopharyngeal carcinoma without distant metastases after AJCC/UACC 8th edition;3.The radiation therapy technique is IMRT;4.Age 18-70 years;5.Has good organ function;6.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.Willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies.

Exclusion Criteria

• 1.Concomitant with other tumors;2.Those with a history of severe immediate allergies to any of the drugs used in this study;3.Lack of or limited capacity for civil conduct;4.Addiction to drugs or alcohol, with a physical or psychiatric disorder;5.Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease;6.Pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	3 Years	The time from the first diagnosis of nasopharyngeal carcinoma to the first observation of disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 Years	The time from the first diagnosis of nasopharyngeal carcinoma to the occurrence of death from any cause
Distant Metastasis-free Survival	3 years	Distant metastasis-free survival (DMFS) was defined as the time from diagnosis to the occurrence of distant metastasis or the date of censoring, whichever came first.
Locoregional Recurrenc-free Survival	3 Years	Locoregional recurrence-free survival (LRRFS) was defined as the time from diagnosis to the occurrence of locoregional recurrence or the date of censoring, whichever came first.

Trial Locations

Locations (1)

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China