An observational study in Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms and Metastasis, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational
Neoadjuvant chemoimmunotherapy (NCIT) is increasingly used for locally advanced esophageal squamous cell carcinoma (ESCC). However, the station-specific distribution of residual lymph node metastasis after NCIT remains incompletely characterized, and whether a pathologic complete response of the primary tumor implies nodal clearance is unclear. This single-center retrospective cohort study included consecutive patients with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy (at least 15 nodes retrieved) between June 2012 and June 2025. Station-specific lymph node metastasis rates were analyzed in the NCIT group (n = 272) according to residual pathologic T category (ypT), and in the upfront surgery group (n = 445) according to pathologic T category (pT). The two groups followed different clinical pathways and were not randomized; between-group comparisons are descriptive only and no causal inference is intended. The study aims to provide an anatomic basis for surgical planning and postoperative risk stratification in middle thoracic ESCC.
Regional lymph node metastasis is one of the most important prognostic determinants in esophageal cancer, and residual nodal disease after neoadjuvant therapy is associated with adverse oncologic outcomes. Primary tumor location determines the pattern of regional nodal spread, and the middle thoracic esophagus has a complex, bidirectional longitudinal lymphatic drainage. Neoadjuvant chemoimmunotherapy (NCIT) has been increasingly adopted for locally advanced ESCC, but data describing the station-specific distribution of residual nodal metastasis after NCIT remain limited.
This is a single-center retrospective cohort study. Consecutive adults with middle thoracic ESCC who underwent esophagectomy with lymphadenectomy between June 2012 and June 2025 at the Army Medical Center of PLA (Daping Hospital) were screened. Eligibility required middle thoracic tumor location, histologically confirmed ESCC, esophagectomy with lymphadenectomy, and at least 15 lymph nodes dissected. Patients with adenocarcinoma or other histologic subtypes, concomitant malignant tumors, or incomplete medical records were excluded. A total of 717 patients were included: 272 in the NCIT group and 445 in the upfront surgery group.
The NCIT group received at least one preoperative cycle, administered every 3 weeks. Chemotherapy consisted of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) combined with a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin). Immunotherapy consisted of a programmed cell death protein 1 (PD-1) inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the discretion of the treating physician. Patients in the upfront surgery group underwent esophagectomy without neoadjuvant therapy.
All patients underwent McKeown esophagectomy with cervical anastomosis and two-field lymphadenectomy, performed 3 to 8 weeks after the last cycle of neoadjuvant therapy in the NCIT group. Nodal stations were recorded according to the AJCC classification (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), and pT and ypT categories were assigned according to the AJCC/UICC 8th edition. Retrieved and positive nodes were counted for each station, and tumor size was measured on the resected specimen along three diameters.
The primary outcome is the station-specific lymph node metastasis rate, analyzed by residual ypT category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group and by pT category (pTis, pT1, pT2, pT3-4) in the upfront surgery group. Stations with metastasis rates above 10%, between 5% and 10%, and below 5% were classified as high-, intermediate-, and low-risk, respectively. Rates based on fewer than 20 dissected nodes are reported with caution. Continuous variables are summarized as mean and standard deviation and compared with the Student t test; categorical variables are summarized as counts and percentages and compared with the chi-square test or Fisher exact test. All tests are two-sided, with a significance level of 0.05.
Because the two cohorts were assembled on different clinical grounds and were not randomized, comparisons between residual ypT disease after NCIT and de novo pT disease after upfront surgery are descriptive and hypothesis-generating; no propensity-score matching or causal comparison was performed. This study was registered retrospectively, after completion of data collection.
675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
This study's enrollment of 717 is above the median of 247 across 86 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 121 studies on the registry; 42 are open to participants now.
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Patients with EC who attended the Department of Thoracic Surgery at Daping Hospital and underwent the McKeown MIE procedure performed by the same surgical team were included for evaluation from Jun 2012 to Jun 2025.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At least one preoperative cycle administered every 3 weeks, consisting of a taxane (paclitaxel, nab-paclitaxel, or docetaxel) plus a platinum agent (cisplatin, carboplatin, lobaplatin, or nedaplatin) plus a PD-1 inhibitor (pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab, or serplulimab). Regimen selection was at the treating physician's discretion.
Esophagectomy with two-field lymphadenectomy without preoperative chemoimmunotherapy, in patients with relatively early-stage disease or who declined neoadjuvant therapy.
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Station-specific lymph node metastasis rate
Proportion of patients with pathologically confirmed metastasis at each AJCC lymph node station (2R, 2L, 4R, 4L, 7, 8U, 8M, 8L, 9, 10, 15, 16, 17, 18, 19, 20), reported separately by residual pathologic T category (ypT0, ypT1, ypT2, ypT3-4) in the NCIT group.
Time frame: At pathologic examination of the esophagectomy specimen; surgery performed between June 2012 and June 2025.
No study locations are listed for this record.
Plan to share: No — No individual participant data will be shared. The data are derived from a retrospective review of medical records, and the institutional ethics committee approval does not permit public deposition of patient-level data.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Esophageal Squamous Cell Carcinoma →
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