[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"la-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:la-hnscc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100591315","phase-2-cetuximab--tislelizumab--chemotherapy-in-the-treatment-of-unresectable-la-hnscc-100591315",false,"NCT06978829","Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC","Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;\n2. Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;\n3. No prior treatment for head and neck squamous cell carcinoma;\n4. No prior treatment with cetuximab or PD-(L)1 inhibitors;\n5. At least one measurable lesion according to RECIST v1.1;\n6. No gender restriction, age ≥18;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n8. Expected survival period ≥ 3 months;\n9. Organ function levels meet the following criteria:\n\n   1. Blood routine: Hemoglobin ≥90 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥90×10\\^9\u002FL;\n   2. Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g\u002FL;\n   3. Cardiac function: Left ventricular ejection fraction \\>50% as shown by echocardiography.\n10. Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);\n2. Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;\n3. Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation \\>470 ms), and grade I cardiac insufficiency;\n4. History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;\n5. Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU\u002FmL) or active hepatitis C (positive hepatitis C antibody) patients;\n6. Patients with active tuberculosis (with exposure history or positive tuberculosis test; accompanied by clinical and\u002For imaging manifestations);\n7. Patients who have undergone major surgery within 4 weeks before the first dose or whose wounds have not fully healed;\n8. Patients with a clear tendency to bleed;\n9. Patients with severe complications such as pyloric obstruction, upper gastrointestinal bleeding, gastrointestinal perforation, obstructive jaundice, severe malnutrition, etc.;\n10. Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;\n11. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor is highly likely to invade important blood vessels during treatment, leading to fatal massive bleeding;\n12. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.;\n13. Patients with active brain metastasis;\n14. Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer);\n15. Pregnant or breastfeeding women;\n16. Patients with severe concomitant diseases that endanger patient safety or affect the completion of the study, as judged by the investigator, and those whom the investigator considers unsuitable for inclusion.","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.",[26],"LA HNSCC",[28,29,26],"Tislelizumab","Cetuximab","RECRUITING","2025-05-12",{"date":33,"type":34},"2025-05-18","ACTUAL",{"date":36,"type":34},"2025-03-01",{"date":38,"type":20},"2027-12-31",{"name":40,"class":41},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"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":51,"type":20},20,[53],"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.",[56,57,26],"SBRT","Neoadjuvant Immunochemotherapy","NOT_YET_RECRUITING","2024-12-05",{"date":61,"type":34},"2024-12-09",{"date":63,"type":20},"2024-12-24",{"date":65,"type":20},"2026-12-26",{"name":67,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]