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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Design and Setting. Multicenter, retrospective cohort study conducted at three affiliated hospitals in China. A total of 363 consecutive ESCC patients met eligibility criteria and were split into a training cohort (n=107), internal validation cohort (n=45), and two external test cohorts (n=129 and n=82).

Population. Inclusion criteria: biopsy-confirmed ESCC; locally advanced disease by AJCC 8th edition (cT1N1-T3N0-3M0) on contrast-enhanced CT; completion of standardized neoadjuvant chemo-immunotherapy; availability of high-quality venous-phase chest CT (slice thickness ≤5 mm) within 14 days before therapy; R0 resection 6-8 weeks post-treatment; and a definitive postoperative pathology report documenting pCR. Key exclusions: non-squamous histology, distant metastasis, synchronous malignancies, poor/no venous-phase imaging, slice thickness \>5 mm, severe artifacts, incomplete tumor visualization, incomplete treatment, or missing endpoints.

Neoadjuvant Regimen and Imaging. Patients generally received two cycles of taxane-platinum chemotherapy (paclitaxel plus cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks prior to surgery. CT imaging was standardized to venous-phase contrast with 1-5 mm slices; scans without venous phase or \>5 mm thickness were excluded. Tumor volumes were delineated by two radiologists; disagreements were adjudicated by a senior radiologist, and features were harmonized via resampling and intensity normalization.

Feature Extraction and Modeling. The pipeline integrated: (1) clinical variables; (2) conventional CT radiomics features (shape, first-order, GLCM, GLRLM, GLSZM, etc.); and (3) 2.5D deep learning slice embeddings aggregated to the patient level using multiple-instance learning (MIL). The 2.5D approach uses adjacent slices in axial/sagittal/coronal planes with ResNet backbones; attention-based MIL plus histogram/BoW-TF-IDF descriptors summarized slice-level predictions. Feature selection used univariate filters, correlation screening, mRMR, and LASSO before training classifiers (logistic regression, SVM, Random Forest, Extra-Trees, LightGBM).

Outcomes and Analysis.

Primary outcome: pCR at surgery (yes/no).

Secondary outcomes: model performance (AUC, sensitivity, specificity, PPV/NPV, calibration) and clinical utility by decision-curve analysis; disease-free survival by Kaplan-Meier analysis.

Ethics. Approved by the Ethics Committee of Nanjing Medical University; informed consent was waived given the retrospective design and use of de-identified data.

Conditions

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Esophageal Squamous Cell Carcinoma Pathological Complete Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ESCC nIT+nCT Surgical Resection Cohort (Multicenter, China)

Adults with biopsy-confirmed esophageal squamous cell carcinoma treated at three centers in China who received standardized neoadjuvant immunotherapy plus taxane-platinum chemotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin) before surgery. Pre-treatment venous-phase chest CT (1-5 mm slices) within 14 days of therapy start was analyzed to extract radiomics and 2.5D deep-learning/MIL features. All patients underwent R0 resection 6-8 weeks post-therapy; pathological complete response (pCR) was determined on surgical specimens. This is an observational cohort used to build and externally validate a multimodal model predicting pCR; no biospecimens are retained and no treatments are assigned by protocol.

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Biopsy-confirmed esophageal squamous cell carcinoma (ESCC). Locally advanced disease per AJCC 8th ed. (cT1N1-T3N0-3M0) on contrast-enhanced CT.

Completed standardized neoadjuvant chemo-immunotherapy (e.g., paclitaxel + cisplatin/carboplatin with camrelizumab every 2-3 weeks) prior to surgery.

High-quality venous-phase chest CT (slice thickness ≤5 mm) obtained within 14 days before therapy start.

Underwent R0 resection 6-8 weeks after therapy. Availability of a definitive postoperative pathology report to ascertain pCR status.

Exclusion Criteria

Non-squamous histology; distant metastasis (M1); synchronous malignancies. Inadequate imaging quality (no venous phase, slice thickness \>5 mm, severe artifacts, or incomplete tumor visualization).

Did not complete the full treatment course or had missing endpoints (e.g., no pathological response record or lost to follow-up).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No