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

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.

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Key information

Conditions

ESCC

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 23, 2026
Registry last updated: Mar 23, 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.

Published trials that share one or more normalized conditions with this study.

Completed