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

NCT07488624 | Completed

• 1 other identifier: 2026-Review-263
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ESCC

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 23, 2026
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)