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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Curative Esophagectomy With Systematic Lymphadenectomy
Procedure/SurgeryAll 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
24 months after curative esophagectomySecondary outcomes
1
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.
Time frame
Up to 24 months after curative esophagectomy2
2-Year Overall Survival Rate
The proportion of participants who are alive at 2 years after curative esophagectomy.
Time frame
24 months after curative esophagectomy3
Locoregional Recurrence Rate
The proportion of participants who develop locoregional recurrence, including recurrence at the primary tumor bed, anastomotic region, or regional lymph nodes.
Time frame
Up to 24 months after curative esophagectomy4
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.
Time frame
Up to 24 months after curative esophagectomyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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