[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651220":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":40,"locations":10,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":10},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance",null,"Patients in this group receive neoadjuvant immunochemotherapy consisting of toripalimab (JS001) 240 mg intravenously on day 3, paclitaxel 175 mg\u002Fm² intravenously on day 1, and cisplatin 75 mg\u002Fm² intravenously on day 1, repeated every 21 days for 2 cycles. Approximately 4-8 weeks after completion of neoadjuvant therapy, patients undergo McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. Following surgery (within 3 weeks ± 3 days, no later than 2.5 months postoperatively), patients receive postoperative toripalimab maintenance therapy at 240 mg intravenously every 3 weeks for up to 8 cycles (approximately 6 months) or until disease progression, unacceptable toxicity, or withdrawal of consent.",[13,14,15],"Drug: Toripalimab","Drug: Paclitaxel","Drug: Cisplatin",{"label":17,"type":10,"description":18,"interventionNames":19},"Neoadjuvant Chemotherapy plus Surgery","Patients in this group receive neoadjuvant chemotherapy consisting of paclitaxel 175 mg\u002Fm² intravenously on day 1 and cisplatin 75 mg\u002Fm² intravenously on day 1, repeated every 21 days for 2 cycles. Approximately 4-8 weeks after completion of neoadjuvant therapy, patients undergo McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. No postoperative maintenance therapy is administered. Patients are followed up according to the same schedule as the experimental group.",[14,15],[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Toripalimab","Recombinant humanized anti-PD-1 monoclonal antibody administered at 240 mg IV on day 3 of each 21-day cycle for 2 cycles preoperatively, followed by 240 mg IV Q3W postoperatively for up to 8 cycles.",[9],[27],"JS001",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Paclitaxel","Administered at 175 mg\u002Fm2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.",[17,9],[33],"PTX",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Cisplatin","Administered at 75 mg\u002Fm2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.",[17,9],[39],"DDP",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Yan Zheng, M.D.\u002FPh.D","CONTACT","(+86)0371-65587610","hnszlyylixiang@163.com",{"name":47,"role":43,"phone":10,"phoneExt":10,"email":45},"Song, M.D.\u002FPh.D",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","YanZheng,MD","Director","100651220","ai-driven-digital-twin-and-drug-simulation-for-esophageal-cancer-100651220",false,"NCT07757022","AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer","Construction of Artificial Intelligence Model for Esophageal Cancer Digital Twin Patients and Drug Efficacy Simulation Verification Based on Supercomputing Platform and Multi-Omics Data","ESCA-DT","Inclusion Criteria:\n\n1. 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.\n2. 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.\n3. No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy).\n4. Preoperative evaluation of organ function indicates no surgical contraindications.\n5. Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment:\n\n   * Hemoglobin ≥ 90 g\u002FL;\n   * White blood cell count ≥ 4.0 × 10\\^9\u002FL;\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n   * Platelet count ≥ 100 × 10\\^9\u002FL;\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN);\n   * ALT and AST ≤ 2.5 × ULN;\n   * International normalized ratio (INR) of prothrombin time ≤ 1.5 × ULN, with activated partial thromboplastin time (APTT) within normal range;\n   * Serum creatinine ≤ 1.5 × ULN.\n6. No prior chemotherapy, radiotherapy, or hormone therapy for malignant tumors; no history of other malignancies, except for prostate cancer patients who received hormone therapy and have achieved disease-free survival (DFS) \\> 5 years.\n7. Expected to achieve R0 resection.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1.\n9. Life expectancy ≥ 3 months.\n10. Women of childbearing potential must agree to use effective contraceptive measures (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. Serum or urine pregnancy test must be negative within 7 days prior to enrollment, and patients must not be breastfeeding. Male patients must agree to use contraceptive measures during the study and for 6 months after study completion.\n11. Patients must voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Patients not meeting the inclusion criteria.\n2. Presence of multiple primary malignancies (synchronous or metachronous).\n3. Active infections requiring systemic treatment.\n4. Requirement for continuous systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) for comorbid conditions.\n5. Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment.\n6. Psychiatric disorders that may affect study compliance.\n7. Known or concurrent hemorrhagic disorders.\n8. Female patients who are pregnant or breastfeeding.\n9. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or other severe pulmonary impairment.\n10. Autoimmune diseases, immunodeficiency states, or history of organ transplantation.\n11. Known hypersensitivity to the study drugs (toripalimab, paclitaxel, cisplatin) or their excipients.\n12. Abnormal coagulation function (PT \\> 16s, APTT \\> 53s, TT \\> 21s, Fib \\\u003C 1.5 g\u002FL), bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy.\n13. Bronchial asthma requiring intermittent use of bronchodilators or medical intervention.\n14. Active hepatitis B (HBV) or hepatitis C (HCV) infection. (Patients who are HBsAg positive or HBcAb positive may be eligible if HBV DNA is below the lower limit of detection\u002Fquantification; patients who are HCV antibody positive may be eligible if HCV RNA is below the lower limit of detection\u002Fquantification.)\n15. Human immunodeficiency virus (HIV) positivity.\n16. Any other condition that, in the investigator's judgment, may compromise patient safety, interfere with study compliance, or preclude successful completion of the study.","ALL","18 Years","75 Years",{"count":64,"type":65},400,"ESTIMATED","OBSERVATIONAL","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.",[69],"Esophageal Cancer",[69,71,72,73,74,75,23],"Computational Medicine","Multi-Omics","Artificial Intelligence","Virtual Clinical Trials","Digital Twin","NOT_YET_RECRUITING","2026-08-10",{"date":79,"type":80},"2026-08-11","ACTUAL",{"date":82,"type":65},"2026-07-30",{"date":84,"type":65},"2028-12",{"name":5,"class":6}]