TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC

NCT07697898 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202606005
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

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.

  24 months after curative esophagectomy

Secondary Outcomes (5)

• Overall Survival

  Up to 24 months after curative esophagectomy

• 2-Year Overall Survival Rate

  24 months after curative esophagectomy

• Locoregional Recurrence Rate

  Up to 24 months after curative esophagectomy

• Distant Metastasis Rate

  Up to 24 months after curative esophagectomy

• Pattern of First Failure

  Up to 24 months after curative esophagectomy

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Thoracic Surgery

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07