A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,931
- 试验地点
- 5
- 主要终点
- 3-year overall survival (OS) rate
研究概览
简要总结
This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .
详细描述
This study is a retrospective real-world study. The diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. In this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018. Patients included in the study will be followed up for survival. The main endpoint is 3-year overall survival (OS) rate; the secondary endpoint are 3-year progression-free survival (PFS) rate, 3-year Local-regional control (LRC) rate, objective response rate (ORR), disease control rate (DCR) and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, no gender limitation;
- •Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
- •Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
- •Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.
排除标准
- •Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
- •Lack of critical evaluation information.
研究组 & 干预措施
study group
Patients of study group were all treated with chemoradiotherapy plus nimotuzumab.
干预措施: nimotuzumab (Drug)
结局指标
主要结局
3-year overall survival (OS) rate
时间窗: Up to 3 years
3-year overall survival (OS) rate
次要结局
- disease control rate (DCR)(Up to 12 months)
- 3-year progression-free survival (PFS) rate(Up to 3 years)
- 3-year Local-regional control (LRC) rate(Up to 3 years)
- objective response rate (ORR)(Up to 12 months)
- Safety as measured by number and grade of adverse events(Up to 3 years)