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NCT Number: NCT07705412

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

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.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji hospital, Wuhan, Hubei 430030

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 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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