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

July 11, 2026 updated by: Zhang Ni, Tongji Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

465

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji hospital, Wuhan, Hubei 430030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Locoregional Recurrence-Free Survival (LRFS)
Time Frame: From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: From the date of surgery to disease recurrence, death, or the last available follow-up, assessed up to 5 years after surgery
Disease-free survival is defined as the time from the date of surgery to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last available follow-up.
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)
Time Frame: From the date of surgery to death or the last confirmed follow-up, assessed up to 5 years after surgery
Overall survival is defined as the time from the date of surgery to death from any cause. Participants who are alive will be censored at the date of the last confirmed follow-up.
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)
Time Frame: From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery
Distant metastasis-free survival is defined as the time from the date of surgery to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Distant metastasis refers to disease recurrence outside the locoregional area. Participants without an event will be censored at the date of the last available follow-up.
From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202512010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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