NCT06762470进行中（未招募）不适用
Prognostic Value of Pretreatment Peripheral Circulating Lymphocyte CD4/CD8 Ratio in Patients with Non-metastatic Nasopharyngeal Carcinoma: a Multi-center Prospective Observational Study
Jiangxi Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Progression Free Survival
时间窗: 3 Years
The time from the first diagnosis of nasopharyngeal carcinoma to the first observation of disease progression or death from any cause
次要结局
- Overall Survival(3 Years)
- Distant Metastasis-free Survival(3 years)
- Locoregional Recurrenc-free Survival(3 Years)
研究者
研究点 (1)
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