[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-immunochemotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-immunochemotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100599590","phase-2-surufatinib-in-combination-with-neoadjuvant-chemo-immunotherapy-and-concurrent-chemoradiotherapy-for-patients-with-unresectable-locally-advanced-esophageal-squamous-cell-carcinoma-100599590",false,"NCT07086469","Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","A Prospective, Single-arm, Phase II Clinical Trial of Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).\n* Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower neck and chest, whole-body bone scintigraphy, or PET\u002FCT; staged as T2-4, N0-3, M0-1 (M1 limited to supraclavicular lymph node metastasis).\n* Male or female patients aged 18 to 80 years.\n* No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.\n* Expected life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Signed and dated informed consent form must be obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Participation in another clinical trial simultaneously, except for observational (non-interventional) studies.\n* Prior use of any targeted therapy.\n* Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).\n* Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, bowel obstruction, active bleeding disorders, or psychiatric\u002Fsocial conditions that may impair compliance with study requirements or the ability to provide informed consent.\n* Performance status (PS) score of 2-4.\n* Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \\\u003C 1000 mL; Absolute neutrophil count (ANC) \\\u003C 1.5 × 10⁹\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Hemoglobin \\\u003C 90 g\u002FL; Creatinine clearance \\\u003C 50 mL\u002Fmin calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin \\> 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 × ULN.\n* Any condition that may interfere with the assessment of efficacy or safety of surufatinib.","ALL","18 Years","80 Years",{"count":20,"type":21},69,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.",[27,28,29,30,31],"Toripalimab","Surufatinib","Neoadjuvant Immunochemotherapy","Chemoradiotherapy","Esophageal Squamous Cell Carcinoma",[27,28,29,30,31],"RECRUITING","2025-11-13",{"date":36,"type":37},"2025-11-17","ACTUAL",{"date":39,"type":37},"2025-07-20",{"date":41,"type":21},"2029-07-19",{"name":43,"class":44},"Sun Yat-sen University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100599735","deep-learning-model-predicts-pathological-complete-response-of-esophageal-squamous-cell-carcinoma-following-neoadjuvant-immunochemotherapy-100599735","NCT07088354","Deep Learning Model Predicts Pathological Complete Response of Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunochemotherapy","DL-ESCC","Inclusion Criteria:\n\n1. Pathologically confirmed esophageal squamous cell carcinoma (ESCC).\n2. Received at least one cycle of neoadjuvant chemotherapy combined with immunotherapy.\n3. Underwent contrast-enhanced chest CT before initiation of neoadjuvant treatment.\n4. Underwent contrast-enhanced chest CT after completion of neoadjuvant treatment and prior to surgery.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignancies.\n2. Received other anti-tumor therapies before or during neoadjuvant chemo-immunotherapy.\n3. Incomplete clinical data.\n4. Poor-quality CT imaging.",{"count":54,"type":21},300,"OBSERVATIONAL","This study aims to develop and validate a deep learning model to predict pathological complete response (pCR) in patients with esophageal squamous cell carcinoma who have undergone neoadjuvant immunochemotherapy. Clinical, imaging, and pathological data from previously treated patients will be collected and analyzed. The model is expected to assist in predicting treatment outcomes and guide personalized therapeutic strategies.",[31,29,58,59],"Pathological Complete Response","Deep Learning",[31,29,59,58],"2025-07-24",{"date":63,"type":37},"2025-07-28",{"date":65,"type":37},"2025-03-01",{"date":67,"type":21},"2026-12-01",{"name":69,"class":44},"Tongji Hospital",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100571610","efficacy-and-safety-of-a-third-course-of-neoadjuvant-immunochemotherapy-combined-with-sbrt-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-patients-with-stable-disease-after-two-treatment-courses-a-single-arm-exploratory-study-100571610","NCT06722495","Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years on the date of signing the informed consent form, male or female.\n2. Histologically and imaging-confirmed T3-4a or N+M0 stage III-IVb (AJCC 8th) HNSCC, patients have received 2-courses of platinum-based chemotherapy and tirilizumab immunotherapy, and whose efficacy is assessed as Stable Disease (SD).\n3. Life expectancy is at least 3 months.\n4. ECOG PS 0-1。\n5. Haematological analysis： 5.1 Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without granulocyte colony-stimulating factor in the last 14 days； 5.2 Absolute T-lymphocyte value ≥ 0.5 times the lower limit of normal value； 5.3 Platelets ≥100×10\\^9\u002FL without transfusion or platelet-boosting drugs in the last 14 days； 5.4 Haemoglobin ≥90g\u002FL without transfusion or erythropoietin use in the last 14 days.\n6. Renal function:\n\n   6.1 Creatinine clearance\\* (Ccr) ≥60 mL\u002Fmin; \\*Ccr will be calculated using the Cockcroft-Gault formula: Ccr = (140-age) × body weight (kg) \u002F \\[0.818 (0.85 for males, 0.85 for females) × blood creatinine (SCr, umol\u002FL) \\] or Ccr = (140-age) × body weight (kg)\u002F \\[72 × blood creatinine (SCr, mg\u002FdL) \\]; 6.2 Creatinine ≤ 1.5 × upper limit of normal (ULN)； 6.3 Routine urinalysis suggests urinary protein ≤ +; 6.4 Quantitative 24-hour urine protein \\\u003C1.0g.\n7. Liver function:\n\n   7.1 Serum total bilirubin (TBil) ≤ 1.5 × ULN; 7.2 AST and ALT ≤ 2.5 × ULN, ≤ 5 × ULN for liver metastases, and TBil ≤ 3 × ULN.\n8. Coagulation: international normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may be enrolled if total T3 (or FT3) and FT4 are within the normal range.\n10. Cardiac enzyme profiles within the normal range (enrolment is also permitted if the investigator's combined judgement is that it is a purely laboratory abnormality of no clinical significance).\n11. Patients must be able to understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any of the antineoplastic therapeutic drug components of this research.\n2. Those who have previously suffered from other malignant tumours and have received radiotherapy.\n3. have uncontrolled clinical symptoms or cardiac disease including, but not limited to, symptomatic congestive heart failure (Grade 2 and above as determined by the New York Heart Association's Functional Class), unstable angina pectoris, acute myocardial ischaemia, and poorly controlled cardiac arrhythmias. Past history of myocarditis and cardiomyopathy.\n4. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, glucocorticoids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.\n5. History of (non-infectious) pneumonia requiring steroids or current pneumonia.\n6. Have active tuberculosis.\n7. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first dose or current clinically active interstitial lung disease.\n8. Active or uncontrolled infection requiring systemic therapy.\n9. History of human immunodeficiency virus (HIV) infection (e.g., HIV-positive).\n10. Liver disease such as cirrhosis, decompensated liver disease; known active hepatitis B (e.g., hepatitis B surface antigen (HBsAg) positive and HBV-DNA \\> upper limit of normal in the laboratory of the research centre) or active hepatitis C virus infection (e.g., HCV antibody positive and HCV RNA level above the lower limit of detection).\n\n    \\*Note: Hepatitis B subjects meeting the following criteria may also be enrolled: 10.1 HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation; 10.2 In subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed.\n11. Have an active bleeding disorder or other history of severe bleeding.\n12. Allogeneic organ transplantation (except corneal transplantation) or allogeneic haematopoietic stem cell transplantation.\n13. Pregnant or breastfeeding, or preparing to become pregnant during the trial period.\n14. Medical, psychological, or social condition that may interfere with the subject's participation in the research or affect the assessment of the results; or other conditions that, in the opinion of the investigator, make enrolment inappropriate, or that, in the opinion of the investigator, present other potential risks that make participation in this research inappropriate.","75 Years",{"count":78,"type":21},20,[80],"NA","Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.",[83,29,84],"SBRT","LA HNSCC","NOT_YET_RECRUITING","2024-12-05",{"date":88,"type":37},"2024-12-09",{"date":90,"type":21},"2024-12-24",{"date":92,"type":21},"2026-12-26",{"name":94,"class":44},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]