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Not yet recruiting NCT07697898

TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC

— Observational Esophageal Squamous Cell Carcinoma (ESCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curative Esophagectomy With Systematic Lymphadenectomy.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma (ESCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Curative Esophagectomy With Systematic Lymphadenectomy
    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.

Primary outcome measures

  • 2-Year Disease-Free Survival Rate [Time frame: 24 months after curative esophagectomy]
Secondary outcome measures (5)
  • Overall Survival [Time frame: Up to 24 months after curative esophagectomy]
  • 2-Year Overall Survival Rate [Time frame: 24 months after curative esophagectomy]
  • Locoregional Recurrence Rate [Time frame: Up to 24 months after curative esophagectomy]
  • Distant Metastasis Rate [Time frame: Up to 24 months after curative esophagectomy]
  • Pattern of First Failure [Time frame: Up to 24 months after curative esophagectomy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07697898 · TJ-IRB202606005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗