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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curative Esophagectomy With Systematic Lymphadenectomy | Procedure | All participants will undergo curative esophagectomy with standard systematic lymphadenectomy according to institutional practice. The study will not intentionally reduce the extent of lymph node dissection. Lymph nodes will be separated, labeled, and recorded by anatomical station for postoperative pathological and exploratory immune microenvironment analyses. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Year Disease-Free Survival Rate | 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. | 24 months after curative esophagectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from curative esophagectomy to death from any cause. Participants who are alive will be censored at the date of last follow-up. | Up to 24 months after curative esophagectomy |
| 2-Year Overall Survival Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18 to 75 years with histologically confirmed thoracic esophageal squamous cell carcinoma who have received neoadjuvant immunochemotherapy and are scheduled to undergo curative esophagectomy with standard systematic lymphadenectomy at participating centers.
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The proportion of participants who are alive at 2 years after curative esophagectomy. |
| 24 months after curative esophagectomy |
| Locoregional Recurrence Rate | The proportion of participants who develop locoregional recurrence, including recurrence at the primary tumor bed, anastomotic region, or regional lymph nodes. | Up to 24 months after curative esophagectomy |
| Distant Metastasis Rate | The proportion of participants who develop distant metastasis, including metastasis to the lung, liver, bone, brain, non-regional lymph nodes, or other distant organs. | Up to 24 months after curative esophagectomy |
| Pattern of First Failure | The site of first recurrence or progression will be classified as local recurrence, regional recurrence, distant metastasis, or mixed recurrence. | Up to 24 months after curative esophagectomy |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |