Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- 2-Year Disease-Free Survival Rate
研究概览
简要总结
This is a prospective, multicenter, observational cohort study of patients with esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy.
The study will not alter the current standard surgical approach. All patients will receive curative esophagectomy and systematic lymph node dissection according to institutional practice. Lymph nodes will be separated and recorded by anatomical station during surgery, followed by station-level pathological assessment. Imaging findings, pathological response, perioperative outcomes, recurrence patterns, disease-free survival, overall survival, and selected immune microenvironment features will be collected and analyzed.
The purpose of this study is to characterize station-level residual lymph node metastasis risk and immune activity after neoadjuvant immunochemotherapy. The findings may help identify candidate lymph node stations for future research on individualized or lymph node-preserving surgical strategies in esophageal squamous cell carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years, regardless of sex.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Histologically confirmed thoracic esophageal squamous cell carcinoma.
- •Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.
- •Clinically resectable locally advanced or locally progressive disease without evidence of distant metastasis.
- •Completed preoperative contrast-enhanced computed tomography of the neck, chest, and abdomen. Positron emission tomography-computed tomography and/or endoscopic ultrasound may be performed if clinically available.
- •Considered by the investigator to be able to tolerate curative esophagectomy and standard systematic lymphadenectomy.
排除标准
- •Non-squamous cell carcinoma histology or concurrent primary malignancy requiring treatment.
- •Previous curative surgery for esophageal cancer or previous radiotherapy for the current esophageal lesion.
- •Evidence of distant metastasis, unresectable disease, or considered unsuitable for curative surgery after multidisciplinary team evaluation.
- •Severe autoimmune disease requiring long-term systemic immunosuppressive therapy.
- •Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that prevents surgery or completion of study-related assessments.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, including poor compliance, inability to complete scheduled follow-up, or inability to provide key study data.
结局指标
主要结局
2-Year Disease-Free Survival Rate
时间窗: 24 months after curative esophagectomy
The proportion of participants who are alive without disease recurrence or distant metastasis at 2 years after curative esophagectomy. Disease-free survival is defined as the time from curative esophagectomy to the first occurrence of local recurrence, regional lymph node recurrence, distant metastasis, or death from any cause. Participants without an event will be censored at the date of last valid follow-up.
次要结局
- Overall Survival(Up to 24 months after curative esophagectomy)
- 2-Year Overall Survival Rate(24 months after curative esophagectomy)
- Locoregional Recurrence Rate(Up to 24 months after curative esophagectomy)
- Distant Metastasis Rate(Up to 24 months after curative esophagectomy)
- Pattern of First Failure(Up to 24 months after curative esophagectomy)
研究者
Zhang Ni
Professor, Department of Thoracic Surgery
Tongji Hospital