TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 75 years, regardless of sex.
Eastern Cooperative Oncology Group performance status of 0 to 1.
Histologically confirmed thoracic esophageal squamous cell carcinoma.
Received neoadjuvant immunochemotherapy and considered suitable for curative surgery after multidisciplinary team evaluation.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Curative Esophagectomy With Systematic Lymphadenectomy
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov