[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-cancer-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-cancer-neck":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,74],{"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":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":50},"100417962","phase-1-a-study-of-cemiplimab-with-chemotherapy-and-immunotherapy-in-people-with-head-and-neck-cancer-100417962",false,"NCT04722523","A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer","A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx\n* Clinical stage T1, N2-3; T2, N1-3, T3\u002FT4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET\u002FCT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +\u002F- chemotherapy.\n\n  ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.\n* Disease must be amenable to surgical resection.\n* The patient must be a surgical candidate.\n\n  1. Hemoglobin \\> 9.0 g\u002FdL\n  2. Absolute neutrophil count (ANC) \\>1.5 x 10\\^9\u002FL\n  3. Platelet count \\>100 x 10\\^9\u002FL\n  4. Serum creatinine \\\u003C1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) \\>30 mL\u002Fmin\n  5. Adequate hepatic function:\n* Total bilirubin \\\u003C1.5 x upper limit of normal ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \\\u003C 3 x ULN\n* Alkaline phosphatase (ALP) \\\u003C2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin \\\u003C3x ULN. Upper central must be documented appropriately as past medical history.\n* Men and woman \\>18 years old\n* Eastern cooperative oncology group performance status \\\u003C 1\n\nExclusion Criteria:\n\n* Prior radiation and systemic therapy for a head and neck cancer.\n* Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.\n* Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years.\n\nExceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.\n\n* Conditions requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.\n* Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.\n* Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n* Any infection requiring hospitalization and\u002For intravenous antibiotic therapy within 2 weeks of the start of treatment.\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.\n\n  1. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards\n  2. Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab.\n  3. Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.\n* History of immune-related pneumonitis with the last 5 years.\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management.\n* Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.\n* Patients with a history of solid organ transplant (exception: corneal transplant)\n* Any medical comorbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that in the opinion of the investigator renders the patient unsuitable for participation in a clinical trial due to high safety risks.\n* Women with a positive serum or urine beta-hCG pregnancy test at screening\u002Fbaseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.\n* Breast-feeding women\n* Women of childbearing potential who are sexually active and aren't willing to practice highly effective contraception prior to the first dose of Cemiplimab, during the study, and for at least 180 days after the last dose. Highly effective contraceptive measures include:\n\n  1. Stable use of combined estrogen and progesterone containing hormonal contraception or progesterone and-only hormonal contraception associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening\n  2. Intrauterine device; intrauterine hormone-releasing system\n  3. Bilateral tubal ligation\n  4. Vasectomized partner and\u002For\n  5. Sexual abstinence","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.",[26,27,28,29,30,31],"Head and Neck Cancer","Head Cancer","Head Cancer Neck","Neck Cancer","Head and Neck Squamous Cell Carcinoma","HNSCC",[33,34,35,26,27,29,30,36,37,38],"Cemiplimab","Platinum-Doublet Chemotherapy","Cetuximab","Memorial Sloan Kettering Cancer Center","20-445","HNSCC)","RECRUITING","2026-03-25",{"date":42,"type":43},"2026-03-30","ACTUAL",{"date":45,"type":43},"2021-01-20",{"date":47,"type":20},"2026-06-20",{"name":36,"class":49},"OTHER",7,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100507292","irec-bio-and-irec-registry-100507292","NCT05885490","IReC-Bio and IReC Registry","Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry","IReC-Bio","Inclusion Criteria:\n\n* Aged over 18 at time of diagnosis.\n* Confirmed clinical, radiological, and\u002F or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.\n* Any mucosal, salivary gland, and thyroid histological subtype\n* Ability to give informed consent.\n* Details of clinical follow-up available\n\nFor IReC-BIO only:\n\n* FFPE blocks(s) or fresh frozen tumour tissue available for collection\n* Two or more tumour-containing blocks available from the same specimen\n\nFor QoL Questionnaires only:\n\n• Patients who have received a diagnosis of rHNC no earlier than 6 weeks prior to study entry\n\nExclusion Criteria:\n\n• Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck\n\nFor IReC-BIO only:\n\n* FFPE tumour samples contain insufficient tumour sample for analysis.\n* Insufficient clinical details available\n\nFor QoL Questionnaires only:\n\n• Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry",{"count":60,"type":20},10000000,"OBSERVATIONAL","IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.\n\nOne of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.\n\nThe purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.\n\nCombining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.",[28],"NOT_YET_RECRUITING","2026-02-09",{"date":67,"type":43},"2026-02-10",{"date":69,"type":20},"2026-04",{"date":71,"type":20},"2050-12",{"name":73,"class":49},"Royal Marsden NHS Foundation Trust",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100544289","phase-2-tirelizumab-in-combination-with-carboplatin-and-polymeric-micellar-paclitaxel-for-neoadjuvant-therapy-in-cn-hnscc-100544289","NCT06366945","Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC","Prospective, Single-arm, Phase II Clinical Study of Tirellizumab Combined With Carboplatin and Paclitaxel Polymer Micelles Neoadjuvant Therapy for cN+ Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\nMales and females ECOG Performance Status 0 or 1. Confirmed pathologic and\u002For cytologic diagnosis of squamous cell carcinoma of head and neck，T2-4N1-3M0（III-IV）（AJCC 8.0） Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx.\n\nWith measurable target lesions by CT or MRI. Adequate bone marrow function. Adequate renal and liver function. Pregnancy test (for patients of childbearing potential) negative at screening. Signed Written Informed Consent.\n\nExclusion Criteria:\n\nPatients who pathologically confirmed non-squamous cell carcinoma Patients who has recurrence or distant metastasis Local lesions have been surgically removed Patients who have received systemic anti-cancer therapy, including hormone therapy Patients who have received treatment targeting PD-1 or PD-L1 Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered) Controlled type 1 diabetes Hypothyroidism(If it can be controlled with hormone replacement therapy) Controlled celiac disease Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.\n\nAny other disease that is not expected to recur without external triggers Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer) Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg\u002Fday of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.\n\nHowever, patients who have currently or previously used any of the following steroid regimens can be selected:\n\nAdrenaline replacement steroids(Prednisone ≤10mg\u002Fday or equivalent dose of similar drugs) Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids which is Systemic absorbed Minimally Prophylactically short-term (≤7 days) use of corticosteroids (for example, allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by contact allergens) Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with potassium, sodium and corrected calcium levels\\> 1 after standard drug treatment or hypoalbuminemia grade ≥ 3 History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.\n\nSevere chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before the first administration of the study drug The patient is known to have been infected with HIV Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA ≥ 500 IU\u002FmL or active hepatitis C virus carriers (HCV) should be excluded.\n\nPatients can be selected who is Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C500 IU\u002FmL) and cured hepatitis C patients.\n\nAny surgery requiring general anesthesia has been performed within 28 days before treatment Have had allogeneic stem cell transplantation or organ transplantation\n\nHave any of the following cardiovascular risk factors:\n\nCardiogenic chest pain within 28 days before treatment(moderate pain that restricts instrumental activities of daily living) Symptomatic pulmonary embolism within 28 days before treatment Acute myocardial infarction within 6 months before treatment Any history of heart failure that has reached Grade III or IV as defined by the New York Heart Association within 6 months before treatment Grade 2 ventricular arrhythmia within 6 months before the first administration of the study drug Have a history of cerebrovascular accident within 6 months before the first administration of the study drug Have a history of severe hypersensitivity to other monoclonal antibodies Patients with treatment toxicity (caused by previous anti-cancer treatments) have not returned to baseline or stabilized, unless it is an AE that is not considered a possible safety risk (such as hair loss, neuropathy, or specific laboratory abnormalities) History of allergic reactions to cisplatin or other platinum-containing compounds Peripheral nerve disease ≥ Grade 2 defined by NCI CTCAE v5.0 standard Have gotten a live vaccine within 4 weeks before treatment(Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used; The vaccine used in the nasal cavity is a live vaccine and is not allowed to be used) Abuse or dependence on alcohol or drugs and Basic medical conditions (including laboratory abnormalities) that are not conducive to the administration of the study drug , affect the interpretation of drug toxicity or AEs, lead to insufficient compliance with the study execution and possible damage The patient participates in another therapeutic clinical study at the same time","75 Years",{"count":83,"type":20},85,[85],"PHASE2","To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis",[30,26,31,28],"2024-04-15",{"date":90,"type":43},"2024-04-16",{"date":92,"type":20},"2024-04-20",{"date":94,"type":20},"2029-05-30",{"name":96,"class":49},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]