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Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Using a Multimodal Model Integrating Clinical, Radiomics, and Deep Learning Features

NCT07181850 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 363

Last updated 2025-09-18

No results posted yet for this study

Summary

This multicenter, retrospective cohort study reviews the medical records and CT scans of adults with esophageal squamous cell carcinoma (ESCC) who received neoadjuvant immunotherapy plus chemotherapy before surgery at three hospitals in China. The goal is to develop and validate a computer-assisted model that predicts which patients achieve a pathological complete response (pCR)-meaning no residual tumor is found at surgery-after preoperative treatment. Accurate pCR prediction may help clinicians personalize care and avoid unnecessary treatments in likely non-responders.

The study includes 363 patients. For each patient, routinely collected clinical information and preoperative venous-phase chest CT images were analyzed. From CT images, both radiomics features and features learned by a "2.5D" deep learning approach with multiple-instance learning (MIL) were extracted. These were combined with clinical variables to create a multimodal prediction model. Model performance will be evaluated using standard metrics and validated in internal and external cohorts.

Patients typically received two cycles of taxane-platinum chemotherapy (paclitaxel with cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks before surgery; CT scans were performed within 14 days prior to starting therapy. Surgery (R0 resection) was performed 6-8 weeks after treatment, and pCR was determined by the postoperative pathology report.

This is an observational study; no treatments are assigned by protocol. The study was approved by the Ethics Committee of Nanjing Medical University, with informed consent waived due to the retrospective design.

Conditions

Interventions

OTHER

Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)

Adults with biopsy-confirmed ESCC received standard neoadjuvant immunochemotherapy before surgery (e.g., camrelizumab with paclitaxel plus cisplatin or carboplatin, typically 2 cycles every 2-3 weeks). Treatments were routine clinical care at participating centers and were not assigned by study protocol; this record captures the exposure for observational modeling of pathological complete response (pCR). Surgery (R0) occurred \~6-8 weeks after therapy.

Sponsors & Collaborators

  • The Affiliated cancer hospital of Nanjing Medical University

    collaborator UNKNOWN

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Nanjing Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2024-12-01
Completion
2025-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07181850 on ClinicalTrials.gov