Postoperative Radiotherapy and Lymph Node Dissection After Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma

NCT07705412 | Completed

• 1 other identifier: TJ-IRB202512010
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, retrospective observational study using existing medical records of patients with esophageal squamous cell carcinoma who received at least two cycles of neoadjuvant immunochemotherapy followed by curative surgery with complete tumor removal and negative surgical margins between January 2021 and December 2024. The main aim of this study is to evaluate whether postoperative radiotherapy is associated with better control of cancer recurrence in the surgical area and regional lymph nodes, and whether this association differs according to the extent and number of lymph nodes removed during surgery. Patients will not be assigned to any treatment as part of this study. Outcomes will be compared according to postoperative radiotherapy status and lymph node dissection characteristics. The primary outcome is locoregional recurrence-free survival. Secondary outcomes include disease-free survival, overall survival, and distant metastasis-free survival. Clinical, surgical, pathological, treatment, and follow-up information will be collected from electronic medical records at six esophageal cancer centers. Approximately 300 patients are expected to be included.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

• Locoregional Recurrence-Free Survival (LRFS)

  From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery

Secondary Outcomes (3)

• Disease-Free Survival (DFS)

  From the date of surgery to disease recurrence, death, or the last available follow-up, assessed up to 5 years after surgery

• Overall Survival (OS)

  From the date of surgery to death or the last confirmed follow-up, assessed up to 5 years after surgery

• Distant Metastasis-Free Survival (DMFS)

  From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery

Interventions

Postoperative Radiotherapy RADIATION

Receipt or nonreceipt of postoperative radiotherapy after R0 esophagectomy was determined during routine clinical care and was not assigned by the study protocol. Information on radiotherapy dose, target volume, treatment schedule, and completion status will be extracted from existing medical records.

Lymph Node Dissection PROCEDURE

Lymph node dissection performed during curative esophagectomy will be evaluated according to the documented anatomical extent of dissection and the number of lymph nodes removed. The surgical procedure was determined during routine clinical care and was not assigned by the study protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from the electronic medical record and hospital information system databases of six esophageal cancer centers. Consecutive patients treated between January 2021 and December 2024 will be screened. Eligible patients will have histologically confirmed esophageal squamous cell carcinoma and will have received neoadjuvant immunochemotherapy followed by curative esophagectomy with R0 resection. Existing demographic, clinical, surgical, pathological, postoperative treatment, and follow-up data will be retrospectively extracted. No treatment or exposure will be assigned by the investigators. All eligible patients will be included in one retrospective cohort, with postoperative radiotherapy and lymph node dissection characteristics evaluated as observed clinical exposures.

You may qualify if:

• Histologically confirmed esophageal squamous cell carcinoma.
• Received at least two cycles of neoadjuvant immunochemotherapy consisting of a PD-1 or PD-L1 inhibitor combined with platinum- and taxane-based chemotherapy.
• Underwent planned curative esophagectomy with R0 resection, defined as microscopically negative surgical margins.
• Operative records and postoperative pathology reports documented the number of lymph nodes removed.
• Complete information on postoperative management was available, including postoperative radiotherapy, systemic therapy, or observation. For patients who received postoperative radiotherapy, information on the radiation field and dose was available.
• At least 12 months of postoperative follow-up information was available.

You may not qualify if:

• Histological type other than esophageal squamous cell carcinoma, including adenocarcinoma or neuroendocrine carcinoma.
• Received neoadjuvant chemoradiotherapy, neoadjuvant immunochemoradiotherapy, neoadjuvant chemotherapy alone, or no neoadjuvant treatment.
• Distant metastatic disease at the initial diagnosis.
• Underwent R1 or R2 resection.
• Death within 90 days after surgery.
• History of another malignancy within 5 years before study entry, except for cured nonmelanoma skin cancer or carcinoma in situ, or a history of thoracic radiotherapy.
• Missing key information required to determine the extent of lymph node dissection, postoperative radiotherapy details, date of recurrence, or date of death.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital, Wuhan, Hubei 430030

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Lymph Node Excision

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: September 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)