Development and Multicenter Validation of a Novel Bio-Anatomical Staging System for Predicting Survival and Tailoring Adjuvant Therapy in ESCC After Neoadjuvant Chemoimmunotherapy.

March 18, 2026 updated by: Zhen-Yu Ding, Sichuan University

The goal of this retrospective observational study is to build and validate a "bio-anatomical" prognostic model for patients with esophageal squamous cell carcinoma (ESCC) who underwent neoadjuvant immunochemotherapy (nICT) followed by radical surgery. The main question it aims to answer is:

Can a "bio-anatomical" prognostic nomogram accurately predict overall survival and help guide individualized post-surgery treatment for ESCC patients after nICT better than traditional staging? Researchers will retrospectively analyze the clinical, pathological (including a new lymph node response indicator), and overall survival data of 414 eligible patients treated across three medical centers between 2019 and 2025.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

414

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
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

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 consists of patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who were treated across three medical centers in China (West China Hospital of Sichuan University, Mianzhu Hospital, and Suining Central Hospital) between 2019 and 2025. This real-world clinical cohort specifically comprises adult patients (aged 18 to 80 years) who received at least one cycle of neoadjuvant immunochemotherapy (nICT) prior to undergoing curative-intent radical esophagectomy.

Description

Inclusion Criteria:

  • Age between 18 and 80 years.
  • Histologically confirmed esophageal squamous cell carcinoma (ESCC).
  • Received at least one cycle of neoadjuvant immunochemotherapy (nICT) preoperatively.
  • Underwent subsequent radical esophagectomy.

Exclusion Criteria:

  • Previous history of other malignant tumors.
  • Received other preoperative anti-tumor treatments (such as radiotherapy) besides nICT.
  • Incomplete clinicopathological or follow-up data.
  • Perioperative 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

Cohorts and Interventions

Group / Cohort
ESCC post-nICT cohort
This cohort includes patients aged 18-80 years with histologically confirmed esophageal squamous cell carcinoma (ESCC) who received at least one cycle of neoadjuvant immunochemotherapy (nICT) followed by radical esophagectomy. Patients were treated across three medical centers between 2019 and 2025.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of diagnosis until the date of death from any cause, assessed up to 120 months.
Defined as the time from the date of confirmed diagnosis to the date of death from any cause or the date of last follow-up.
From date of diagnosis until the date of death from any cause, assessed up to 120 months.

Collaborators and Investigators

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

Sponsor

Sichuan University

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)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-Review-263

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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