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

NCT07181850 | Completed

• 2 other identifiers: KY-2024-373-0181903992
• Study Type: observational
• Target: 363
• Locations: 1 country
• Sites: 1

Brief 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

Esophageal Squamous Cell Carcinoma; Pathological Complete Response

Keywords

Deep Learning; Multiple Instance Learning (MIL)

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) at Surgery

  pCR is defined as no residual viable tumor in the resected specimen (esophagus and regional lymph nodes) after neoadjuvant immunotherapy plus chemotherapy. pCR status is determined from the postoperative surgical pathology report. This is an observational cohort; treatments were standard-of-care and not assigned by protocol. pCR is abstracted from medical records for all eligible patients.

  At time of surgery after neoadjuvant therapy (~6-8 weeks post-treatment).

Secondary Outcomes (1)

• Diagnostic Performance of the Multimodal Model for Predicting pCR

  From baseline CT (≤14 days before therapy start) to surgery (≈6-8 weeks post-therapy); analysis performed at study completion.

Study Arms (1)

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with biopsy-confirmed ESCC treated at three participating centers in China. Patients received standard neoadjuvant chemo-immunotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin), had pre-treatment venous-phase chest CT within 14 days, and underwent R0 resection 6-8 weeks post-therapy. pCR status was determined from surgical pathology. Sites include: The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University; Nanjing Medical University Affiliated Cancer Hospital \& Jiangsu Cancer Hospital \& Jiangsu Institute of Cancer Research; and Nanjing Drum Tower Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanjing Medical University: lead
• The Affiliated cancer hospital of Nanjing Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University

Huai'an, Jiangsu, 223000, China

Location

Related Publications (4)

• Fan L, Yang Z, Chang M, Chen Z, Wen Q. CT-based delta-radiomics nomogram to predict pathological complete response after neoadjuvant chemoradiotherapy in esophageal squamous cell carcinoma patients. J Transl Med. 2024 Jun 18;22(1):579. doi: 10.1186/s12967-024-05392-4.

  PMID: 38890720 RESULT

• Liu Y, Wang Y, Wang X, Xue L, Zhang H, Ma Z, Deng H, Yang Z, Sun X, Men Y, Ye F, Men K, Qin J, Bi N, Wang Q, Hui Z. MR radiomics predicts pathological complete response of esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a multicenter study. Cancer Imaging. 2024 Jan 23;24(1):16. doi: 10.1186/s40644-024-00659-x.

  PMID: 38263134 RESULT

• Guo X, Chen C, Zhao J, Wang C, Mei X, Shen J, Lv H, Han Y, Wang Q, Lv J, Chen H, Yan X, Liu Z, Zhang Z, Zhong Q, Jiang Y, Xu L, Li X, Qian D, Ma D, Ye M, Wang C, Wang Z, Lin J, Tian Z, Leng X, Li Z. Neoadjuvant Chemoradiotherapy vs Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma. JAMA Surg. 2025 May 1;160(5):565-574. doi: 10.1001/jamasurg.2025.0220.

  PMID: 40105813 RESULT

• Zheng Y, Liang G, Yuan D, Liu X, Ba Y, Qin Z, Shen S, Li Z, Sun H, Liu B, Gao Q, Li P, Wang Z, Liu S, Zhu J, Wang H, Ma H, Liu Z, Zhao F, Zhang J, Zhang H, Wu D, Qu J, Ma J, Zhang P, Ma W, Yan M, Yu Y, Li Q, Zhang J, Xing W. Perioperative toripalimab plus neoadjuvant chemotherapy might improve outcomes in resectable esophageal cancer: an interim analysis of a phase III randomized clinical trial. Cancer Commun (Lond). 2024 Oct;44(10):1214-1227. doi: 10.1002/cac2.12604. Epub 2024 Sep 2.

  PMID: 39221992 RESULT

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: July 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)