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

Not yet recruiting

• Conditions: Esophageal Cancer; Neoadjuvant Therapy

• Registration Number: NCT07203690
• Lead Sponsor: Henan Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-12-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (pCR) Rate	January 2025 - December 2027	The proportion of patients achieving pathological complete response (ypT0 ypN0) after neoadjuvant therapy.
Overall Survival (OS)	January 2025 - December 2027	The time from treatment initiation to death from any cause.
Event-Free Survival (EFS)	January 2025 - December 2027	The time from treatment initiation to disease progression, recurrence, new primary cancer, or death.
Disease-Free Survival (DFS)	January 2025 - December 2027	The time from curative-intent surgery to disease recurrence or death.