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NCT Number: NCT07697898

TDLN-Guided Lymphadenectomy After Neoadjuvant Immunochemotherapy for ESCC

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 2-Year Disease-Free Survival Rate

    Time frame: 24 months after curative esophagectomy

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: Up to 24 months after curative esophagectomy

    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.

  2. 2-Year Overall Survival Rate

    Time frame: 24 months after curative esophagectomy

    The proportion of participants who are alive at 2 years after curative esophagectomy.

  3. Locoregional Recurrence Rate

    Time frame: Up to 24 months after curative esophagectomy

    The proportion of participants who develop locoregional recurrence, including recurrence at the primary tumor bed, anastomotic region, or regional lymph nodes.

  4. Distant Metastasis Rate

    Time frame: Up to 24 months after curative esophagectomy

    The proportion of participants who develop distant metastasis, including metastasis to the lung, liver, bone, brain, non-regional lymph nodes, or other distant organs.

  5. Pattern of First Failure

    Time frame: Up to 24 months after curative esophagectomy

    The site of first recurrence or progression will be classified as local recurrence, regional recurrence, distant metastasis, or mixed recurrence.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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