Esophagus CancerNCT07063901
Multimodal Deep Learning for Predicting Treatment Response to Neoadjuvant Chemoimmunotherapy in Esophageal Cancer
An observational study of Esophagus Cancer, run by Central South University at 1 site in China.
Trial summary
This observational study aims to investigate a clinical cohort of patients with locally advanced esophageal cancer undergoing neoadjuvant chemoimmunotherapy. By integrating multimodal clinical data-including demographic characteristics, medical history, imaging studies, pathological findings, and laboratory tests-and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagus Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with esophageal cancer who received neoadjuvant therapy at the Second Xiangya Hospital of Central South University
Who may be able to join
- Patients with histologically confirmed esophageal cancer based on biopsy results;
- Patients recommended for neoadjuvant chemoimmunotherapy following multidisciplinary team (MDT) discussion or evaluation by thoracic surgery specialists;
- Patients who received neoadjuvant chemoimmunotherapy;
- Patients with complete imaging data before and after neoadjuvant treatment.
Who cannot join
- Patients deemed eligible for surgery by the thoracic surgery team but who refused surgical treatment;
- Patients with missing or poor-quality CT images;
- Patients with concurrent malignancies other than esophageal cancer;
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Ping Jiang, +8673185292476, xy2gcpjiang@163.com
About this study
This observational study aims to investigate a clinical cohort of patients with locally advanced esophageal cancer undergoing neoadjuvant chemoimmunotherapy. By integrating multimodal clinical data-including demographic characteristics, medical history, imaging studies, pathological findings, and laboratory tests-and employing deep learning algorithms, the study seeks to develop predictive models for the early and accurate assessment of treatment response prior to surgery. Specifically, this study focuses on addressing the following key scientific questions:
- Can multimodal clinical data be used to construct an accurate model for predicting pathological complete response (pCR) following neoadjuvant therapy?
- Can deep learning models enable early identification of patients with suboptimal response to neoadjuvant therapy, defined as stable disease (SD) or progressive disease (PD), before surgery?
- Conditions
- Esophagus Cancer
- 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 |
|---|---|---|
| group 1: pCR | group 1: Pathologic Complete Response | |
| group 2: Non-pCR | group 2: Non-Pathological Complete Response | |
| group 3: Non-Favorable Responses | group 3: SD/PD | |
| group 4: Favorable Response | group 4: Non-SD/PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathologic Complete Response
Measured: From enrollment to the end of surgery
Secondary outcomes (1)
Non-Favorable Responses
stable disease/progressive disease
Measured: From enrollment to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Chen, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063901
- Sponsor's protocol ID
- LYF20250118
- Status last verified
- May 2026
- First submitted
- 3 Jul 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Deep Learning for Predicting Treatment Response to Neoadjuvant Chemoimmunotherapy in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07063901
- Acronym / sponsor ID
- LYF20250118
- Conditions
- Esophagus Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 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.
This observational study aims to investigate a clinical cohort of patients with locally advanced esophageal cancer undergoing neoadjuvant chemoimmunotherapy. By integrating multimodal clinical data-including demographic characteristics, medical history, imaging studies, pathological findings, and laboratory tests-and employing deep learning algorithms, the study seeks to develop predictive models for the early and accurate assessment of treatment response prior to surgery. Specifically, this study focuses on addressing the following key scientific questions:
- Can multimodal clinical data be used to construct an accurate model for predicting pathological complete response (pCR) following neoadjuvant therapy?
- Can deep learning models enable early identification of patients with suboptimal response to neoadjuvant therapy, defined as stable disease (SD) or progressive disease (PD), before surgery?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1: pCR | – | –group 1: Pathologic Complete Response |
| group 2: Non-pCR | – | –group 2: Non-Pathological Complete Response |
| group 3: Non-Favorable Responses | – | –group 3: SD/PD |
| group 4: Favorable Response | – | –group 4: Non-SD/PD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with esophageal cancer who received neoadjuvant therapy at the Second Xiangya Hospital of Central South University
Key inclusion criteria (4 listed)
- Patients with histologically confirmed esophageal cancer based on biopsy results;
- Patients recommended for neoadjuvant chemoimmunotherapy following multidisciplinary team (MDT) discussion or evaluation by thoracic surgery specialists;
- Patients who received neoadjuvant chemoimmunotherapy;
- Patients with complete imaging data before and after neoadjuvant treatment.
Key exclusion criteria (4 listed)
- Patients deemed eligible for surgery by the thoracic surgery team but who refused surgical treatment;
- Patients with missing or poor-quality CT images;
- Patients with concurrent malignancies other than esophageal cancer;
- Patients with incomplete clinical data.
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
pCR
Time frame: From enrollment to the end of surgery
Pathologic Complete Response
1 secondary outcome
Non-Favorable Responses
Time frame: From enrollment to the end of surgery
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer, run by Central South University at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chen Chen (+8673185295188, chenchen1981412@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: From enrollment to the end of surgery). 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 7 Jul 2026.