跳至主要内容
临床试验/NCT06727162
NCT06727162招募中不适用

The Value of Contrast-enhanced Ultrasound in Assessing the Response of Cervical Lymph Nodes After Neoadjuvant Chemoimmunotherapy for Head and Neck Squamous Cell Carcinoma

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

The head and neck squamous cell carcinoma is the sixth most common malignant tumor worldwide. For patients with locally advanced head and neck cancer, neoadjuvant therapy is recommended before surgery, including neoadjuvant chemotherapy and immunotherapy. There is a significant variation in patients' responses to neoadjuvant therapy, with approximately 37%-52% of patients achieving a complete pathological response after neoadjuvant therapy. Current research mainly focuses on the efficacy evaluation of the primary tumor, while there is less research on the treatment efficacy evaluation of cervical lymph nodes. In clinical practice, accurate assessment of the status of cervical lymph nodes after neoadjuvant chemoimmunotherapy in patients with squamous cell carcinoma of the head and neck can directly affect the choice of treatment plan by clinicians, reducing unnecessary neck dissection. In recent years, contrast-enhanced ultrasound has been widely used in the diagnosis of thyroid cancer and other head and neck tumors, as well as in the assessment of the benign and malignant nature of cervical lymph nodes. This study aims to explore the value of contrast-enhanced ultrasound in the assessment of cervical lymph nodes after neoadjuvant chemoimmunotherapy in squamous cell carcinoma of the head and neck, in order to guide clinicians in formulating personalized treatment plans.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • (1) Histopathologically confirmed head and neck squamous cell carcinoma; (2) Received neoadjuvant chemoimmunotherapy; (3) Diagnosed with cN+ by CT/MRI before treatment; (4) Underwent radical surgical treatment plus cervical lymph node dissection at this center.

排除标准

  • (1) Did not receive a full course of neoadjuvant therapy; (2) History of treatment for head and neck; (3) Clinical evidence of distant metastasis found during preoperative examination.

结局指标

主要结局

Sensitivity

时间窗: From enrollment to the end of surgery at 10 weeks

Sensitivity = True Positives / (True Positives + False Negatives).

Specificity

时间窗: From enrollment to the end of surgery at 10 weeks

Specificity = True Negatives / (True Negatives + False Positives).

Positive Predictive Value

时间窗: From enrollment to the end of surgery at 10 weeks

Positive Predictive Value = True Positives / (True Positives + False Positives)

Negative Predictive Value

时间窗: From enrollment to the end of surgery at 10 weeks

Negative Predictive Value = True Negatives / (True Negatives + False Negatives)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验