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COMPLETED
NCT07705412

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Postoperative Radiotherapy and Lymph Node Dissection on Recurrence and Distant Metastasis After Neoadjuvant Immunochemotherapy and R0 Resection for Esophageal Squamous Cell Carcinoma: A Multicenter Retrospective Real-World Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

465

Start Date

2025-09-01

Completion Date

2026-06-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

RADIATION

Postoperative Radiotherapy

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.

PROCEDURE

Lymph Node Dissection

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.

Locations (1)

Tongji hospital, Wuhan, Hubei 430030

Wuhan, Hubei, China