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Deep Learning Model Predicts Pathological Complete Response of Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunochemotherapy

Deep Learning Model Predicts Pathological Complete Response of Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunochemotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07088354
Acronym
DL-ESCC
Enrollment
300
Registered
2025-07-28
Start date
2025-03-01
Completion date
2026-12-01
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Learning, Esophageal Squamous Cell Carcinoma, Neoadjuvant Immunochemotherapy, Pathological Complete Response

Keywords

Esophageal Squamous Cell Carcinoma, Neoadjuvant Immunochemotherapy, Deep Learning, Pathological Complete Response

Brief summary

This study aims to develop and validate a deep learning model to predict pathological complete response (pCR) in patients with esophageal squamous cell carcinoma who have undergone neoadjuvant immunochemotherapy. Clinical, imaging, and pathological data from previously treated patients will be collected and analyzed. The model is expected to assist in predicting treatment outcomes and guide personalized therapeutic strategies.

Detailed description

This multicenter retrospective study will collect chest CT images and clinical data from patients with esophageal squamous cell carcinoma (ESCC) who underwent surgery following neoadjuvant immunochemotherapy between January 2019 and July 2025. Deep learning features will be extracted from the CT images to develop a predictive model of pathological complete response (pCR). The model's performance will be evaluated using metrics including the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Additionally, SHapley Additive exPlanations (SHAP) analysis will be employed to quantify the contribution of CT imaging features to the model's predictions. This study aims to improve early identification of responders to neoadjuvant immunochemotherapy and support personalized treatment strategies for ESCC patients.

Interventions

DIAGNOSTIC_TESTThe high-throughput extraction of large amounts of quantitative image features from medical images

The high-throughput extraction of large amounts of quantitative image features from medical images

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Pathologically confirmed esophageal squamous cell carcinoma (ESCC). 2. Received at least one cycle of neoadjuvant chemotherapy combined with immunotherapy. 3. Underwent contrast-enhanced chest CT before initiation of neoadjuvant treatment. 4. Underwent contrast-enhanced chest CT after completion of neoadjuvant treatment and prior to surgery.

Exclusion criteria

1. Diagnosis of other malignancies. 2. Received other anti-tumor therapies before or during neoadjuvant chemo-immunotherapy. 3. Incomplete clinical data. 4. Poor-quality CT imaging.

Design outcomes

Primary

MeasureTime frameDescription
Pathological Complete Response (pCR) RateAssessed at the time of surgery, within 1 month post-treatment.The proportion of patients achieving complete pathological remission after neoadjuvant immunochemotherapy followed by surgery.

Secondary

MeasureTime frameDescription
Model Performance Metrics (AUC, Accuracy, Sensitivity, Specificity, PPV, NPV)At the time of model validation, approximately one year on average after the completion of the research.Evaluation of the deep learning model's predictive performance using receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Countries

China

Contacts

Primary ContactYangkai Li, MD, PhD
doclyk@163.com+8613995516396
Backup ContactLin Zhou, MSc
zhoul0928@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026