CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 363 enrolled
Drug / intervention
Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)other
Likely dose
Not stated in record
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Search/NCT07181850
NCT07181850N/ACompleted

Integration of Clinical, Radiomics, and 2.5D Deep Learning-Based Multiple Instance Learning Features for Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunotherapy and Chemotherapy: A Multicenter Comparative Study

Nanjing Medical University·observational·Posted Sep 18, 2025·Updated Sep 18, 2025

In Brief

An observational study evaluating Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT) for Esophageal Squamous Cell Carcinoma and Pathological Complete Response. Completed, enrolled 363 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 18, 2025
Enrollment StartJan 1, 2019
Primary CompletionDec 1, 2024
Study CompletionJul 31, 2025
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9 months ago

Interventions

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

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.