Clinical trial · Observational
Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Using a Multimodal Model Integrating Clinical, Radiomics, and Deep Learning Features
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pathological Complete Response | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ESCC nIT+nCT Surgical Resection Cohort (Multicenter, China)
- description
- 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.
- interventionNames
- Other: Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) at Surgery
- timeFrame
- At time of surgery after neoadjuvant therapy (~6-8 weeks post-treatment).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (4)
- RESULTFan 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
- RESULTLiu 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
- RESULTGuo 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
- RESULTZheng 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