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NCT Number: NCT07088354

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Lin Zhou, MSc

CONTACT

[email protected]

Yangkai Li, MD, PhD

CONTACT

[email protected]

+8613995516396

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Pathological Complete Response (pCR) Rate

    Time frame: Assessed 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 outcomes

  1. Model Performance Metrics (AUC, Accuracy, Sensitivity, Specificity, PPV, NPV)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Zhou, MSc

CONTACT

[email protected]

Yangkai Li, MD, PhD

CONTACT

[email protected]

+8613995516396

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Acronym: DL-ESCC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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