TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC

Tumor-Draining Lymph Node Preservation-Guided Intraoperative Lymphadenectomy After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Observational Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
• Intervention / Treatment: Procedure: Curative Esophagectomy With Systematic Lymphadenectomy

• Study Type: Observational
• Enrollment (Estimated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: TJ-IRB202606005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No