About this trial
This study aims to integrate multi-omics data (genomics, transcriptomics, proteomics) from esophageal cancer patients with artificial intelligence and digital twin technology to construct personalized virtual patient models that precisely simulate individual responses to targeted therapies. Through a drug simulation platform, this study will rapidly screen potential effective drug combinations and optimize dosage and treatment regimens. The project attempts to replace portions of traditional clinical trials with virtual clinical trial technology, substantially shortening the R\&D cycle, reducing costs, and effectively addressing the complexity of individualized treatment. Specifically, this study will conduct a head-to-head virtual clinical trial parallel to a real-world investigator-initiated trial (IIT) in patients with locally advanced esophageal squamous cell carcinoma, comparing the efficacy predictions from the virtual model with actual clinical outcomes. The ultimate goal is to explore the application of large-scale AI models in esophageal cancer targeted therapy, provide personalized treatment recommendations, and advance the implementation of precision medicine in esophageal cancer.
Eligibility criteria
Qualifiers
Treatment-naïve patients with clinical stage locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma, according to the 8th UICC-TNM staging system.
Cervical color Doppler ultrasound shows no suspicious metastatic lymph nodes, or patients with suspected lymph node metastasis on ultrasound who are eligible for three-field lymphadenectomy.
No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy).
Preoperative evaluation of organ function indicates no surgical contraindications.
Disqualifiers
Patients not meeting the inclusion criteria.
Presence of multiple primary malignancies (synchronous or metachronous).
Active infections requiring systemic treatment.
Requirement for continuous systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) for comorbid conditions.
Trial design
Treatments tested in this trial
- Toripalimab
- Paclitaxel
- Cisplatin