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

October 1, 2025 updated by: Qujinrong, Henan Cancer Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinrong Qu
  • Phone Number: (86) 0371-65587595
  • Email: qjryq@126.com

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

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.

Description

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 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
Multimodal AI Esophageal Carcinoma Cohort Protocol
Efficacy and Prognosis of Different Treatment Modalities for Esophageal Squamous Cell Carcinoma

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Collaborators

Guangdong Provincial People's Hospital
Xinyang Central Hospital

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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Estimated)

October 2, 2025

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-066 (Other Identifier: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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