Esophageal CancerNCT07203690
Development and Application of AI-Based Therapeutic Strategies for Esophageal Cancer Integrating Multimodal Imaging and Digital Pathology
An observational study of Esophageal Cancer and Neoadjuvant Therapy, run by Henan Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Neoadjuvant Therapy
- How many people
- 7,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18-70 years;
- Histologically confirmed esophageal carcinoma by biopsy;
- No prior antitumor therapy received.
Who cannot join
- Contraindications to MRI examination;
- Poor compliance with antitumor therapy;
- Unwillingness to participate in the study;
- Image quality inadequate for diagnostic requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal AI Esophageal Carcinoma Cohort Protocol | Efficacy and Prognosis of Different Treatment Modalities for Esophageal Squamous Cell Carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
The proportion of patients achieving pathological complete response (ypT0 ypN0) after neoadjuvant therapy.
Measured: January 2025 - December 2027
Overall Survival (OS)
The time from treatment initiation to death from any cause.
Measured: January 2025 - December 2027
Event-Free Survival (EFS)
The time from treatment initiation to disease progression, recurrence, new primary cancer, or death.
Measured: January 2025 - December 2027
Disease-Free Survival (DFS)
The time from curative-intent surgery to disease recurrence or death.
Measured: January 2025 - December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Xinyang Central Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Qujinrong, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203690
- Sponsor's protocol ID
- 2025-066
- Status last verified
- Jan 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of AI-Based Therapeutic Strategies for Esophageal Cancer Integrating Multimodal Imaging and Digital Pathology
- ClinicalTrials.gov ID
- NCT07203690
- Acronym / sponsor ID
- 2025-066
- Conditions
- Esophageal Cancer, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Xinyang Central Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal AI Esophageal Carcinoma Cohort Protocol | – | –Efficacy and Prognosis of Different Treatment Modalities for Esophageal Squamous Cell Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18-70 years;
- Histologically confirmed esophageal carcinoma by biopsy;
- No prior antitumor therapy received.
Key exclusion criteria (4 listed)
- Contraindications to MRI examination;
- Poor compliance with antitumor therapy;
- Unwillingness to participate in the study;
- Image quality inadequate for diagnostic requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: January 2025 - December 2027
The proportion of patients achieving pathological complete response (ypT0 ypN0) after neoadjuvant therapy.
Overall Survival (OS)
Time frame: January 2025 - December 2027
The time from treatment initiation to death from any cause.
Event-Free Survival (EFS)
Time frame: January 2025 - December 2027
The time from treatment initiation to disease progression, recurrence, new primary cancer, or death.
Disease-Free Survival (DFS)
Time frame: January 2025 - December 2027
The time from curative-intent surgery to disease recurrence or death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Neoadjuvant Therapy, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinrong Qu ((86) 0371-65587595, qjryq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: January 2025 - December 2027). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.