Development and Application of AI-Based Therapeutic Strategies for Esophageal Cancer Integrating Multimodal Imaging and Digital Pathology

NCT07203690 | Not Yet Recruiting

• 1 other identifier: 2025-066
• Study Type: observational
• Target: 7,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to conduct a multi-center, big data study to create a neural network decision model for predicting treatment efficacy and prognosis based on multi-modal, multi-temporal imaging features combined with tumor microenvironment scores. It will also use various model interpretation techniques to clarify the role and mechanism of key biomarkers or strongly associated biomarker groups in treatment efficacy and prognosis. Ultimately, it aims to achieve the research and application of AI treatment strategies combining multi-modal imaging and digital pathology to guide clinicians in the personalized treatment strategies for patients with esophageal squamous cell carcinoma.

Conditions

Esophageal Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (4)

• Pathological Complete Response (pCR) Rate

  The proportion of patients achieving pathological complete response (ypT0 ypN0) after neoadjuvant therapy.

  January 2025 - December 2027

• Overall Survival (OS)

  The time from treatment initiation to death from any cause.

  January 2025 - December 2027

• Event-Free Survival (EFS)

  The time from treatment initiation to disease progression, recurrence, new primary cancer, or death.

  January 2025 - December 2027

• Disease-Free Survival (DFS)

  The time from curative-intent surgery to disease recurrence or death.

  January 2025 - December 2027

Study Arms (1)

Multimodal AI Esophageal Carcinoma Cohort Protocol

Efficacy and Prognosis of Different Treatment Modalities for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 7,000 esophageal carcinoma patients from multiple centers. Participants will receive CT and mpMRI scans before, during, and after treatment, as required for evaluating surgery, neoadjuvant therapy, or definitive chemoradiation. PET-CT will be performed if distant metastasis is suspected. Whole-slide digital scanning will be applied to biopsy and surgical specimens for pathological analysis.

You may qualify if:

• Aged 18-70 years;
• Histologically confirmed esophageal carcinoma by biopsy;
• No prior antitumor therapy received.

You may not qualify if:

• Contraindications to MRI examination;
• Poor compliance with antitumor therapy;
• Unwillingness to participate in the study;
• Image quality inadequate for diagnostic requirements.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Xinyang Central Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Jinrong Qu

CONTACT

(86) 0371-65587595; qjryq@126.com

Study Design

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

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-01