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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Diagnosis of other malignancies.

Received other anti-tumor therapies before or during neoadjuvant chemo-immunotherapy.

Incomplete clinical data.

Poor-quality CT imaging.

Trial population

Patients diagnosed with esophageal squamous cell carcinoma who received at least one cycle of neoadjuvant chemotherapy combined with immunotherapy, with available contrast-enhanced chest CT scans before and after neoadjuvant treatment, and who underwent surgical resection.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: ESCC Patients Undergoing Neoadjuvant Immunochemotherapy and Surgery1 intervention

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR) Rate

The proportion of patients achieving complete pathological remission after neoadjuvant immunochemotherapy followed by surgery.

Time frame
Assessed at the time of surgery, within 1 month post-treatment.

Secondary outcomes

1

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

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).

Time frame
At the time of model validation, approximately one year on average after the completion of the research.

Other outcomes

Sponsors and contacts

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