[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypopharyngeal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypopharyngeal-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,69,104,142],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100612082","phase-2-neoadjuvant-chemotherapy-combined-with-finotonlimab-in-the-treatment-of-locally-advanced-hypopharyngeal-carcinoma-100612082",false,"NCT07248956","Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma","Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n1. Willingness to provide written informed consent;\n2. Age ≥18 and ≤75 years;\n3. Treatment-naïve for malignant disease;\n4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;\n5. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding status;\n2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;\n3. Poorly controlled cardiovascular conditions or other diseases;\n4. Active or documented history of autoimmune diseases requiring systemic treatment;\n5. Synchronous or metachronous malignancies;\n6. Other conditions deemed ineligible for the study by investigators.","ALL","18 Years","75 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multi-center, randomized controlled, prospective clinical study.",[27],"Hypopharyngeal Carcinoma",[29,30,31],"PD-1 inhibitor","neoadjuvant therapy","locally advanced","RECRUITING","2025-12-22",{"date":35,"type":36},"2025-12-23","ACTUAL",{"date":33,"type":36},{"date":39,"type":21},"2029-12-30",{"name":41,"class":42},"Eye & ENT Hospital of Fudan University","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100477225","the-management-of-metastatic-neck-nodes-in-n23-hypopharyngeal-squamous-cell-carcinoma-100477225","NCT05494190","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma","The Management of Metastatic Neck Nodes in N2\u002F3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study","Inclusion Criteria:\n\n1. Able to understand and willing to sign a written informed consent document.\n2. Age ≥ 18 and ≤ 75 years.\n3. Male or female.\n4. Karnofsky physical status (KPS): ≥ 80\n5. Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal. Kidney function: Serum creatinine \\\u003C upper limit of normal value and creatinine clearance rate \\> 60 ml\u002F(min\\*1.73m2) (Cockcroft-Gault formula). Blood test: neutrophil (Neu) ≥ 1.5×109\u002FL, platelet (PLT) ≥ 100×109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.\n7. After clinical and radiographic evaluations, clinically classified as T1\u002F2 N2\u002F3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).\n8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).\n9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).\n10. Radical treatment intent.\n11. Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and\u002For bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.\n12. Good compliance.\n\nExclusion Criteria:\n\n1. Distant metastatic disease\n2. Have a history of other cancers or coinstantaneous second primary tumor\n3. Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.\n4. Patients who have participated in other clinical trials within 1 month before the test.\n5. Patients estimated to have poor tolerance to induction chemotherapy.\n6. The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time \\[within the past year\\] or active suicidal ideation or behavior).\n7. Palliative treatment intent.\n8. Pregnant or lactating women.",{"count":52,"type":21},111,[54],"NA","This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.",[27],[58,59,60],"Metastatic Neck Nodes","Induction Chemotherapy","Neck Dissection",{"date":62,"type":36},"2025-12-30",{"date":64,"type":36},"2022-11-01",{"date":66,"type":21},"2027-11",{"name":41,"class":42},3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100574642","phase-1-thermoradiotherapy-for-locally-advanced-head-and-neck-cancer-patients-100574642","NCT06761937","Thermoradiotherapy for Locally Advanced Head and Neck Cancer Patients","Thermoradiotherapy for Locally Advanced Head and Neck CAncer Patients - a Phase I Trial.","TANCA-I","Inclusion Criteria:\n\n* Age \\>= 18 years\n* WHO 0-1\n* Mouth opening before treatment of \\>= 40 mm for women and \\>= 45mm for men\n* Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx proven by cytology \u002F histology.\n* Locally advanced disease (stage III-IV).\n* Curative intend treatment with radiotherapy in the primary setting with a contraindication for systemic adjuvant treatment.\n* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients previously treated by radiation on the same target volume.\n* Any condition or circumstance potentially hampering compliance with the follow-up schedule.\n* Patients having pacemakers or clustered metal markers (with a total length \\>2 cm of metal markers in direct contact).\n* Tumor location caudal to a tracheostomy (this prevents penetration of the microwaves to the tumor).\n* Anatomical boundaries of the shoulders prohibiting positioning of the applicator.",{"count":78,"type":21},30,[80],"PHASE1","Patients with head and neck cancer treated with radiotherapy (RT) have a substantial change of recurrence of the tumor in the pharynx or lymph nodes in the neck. Once tumor and\u002For lymph nodes have recurred, the prognosis is poor. To increase the efficacy of RT, usually chemotherapy is added to the treatment. However, due to age or co-morbidity chemotherapy is not always feasible to give in all patients. In head and neck patients unfit for chemotherapy, there is a clinical need to increase the effectiveness of RT, without adding substantial toxicity. To this end, the use of thermotherapy in this disease site is investigated.\n\nThe goal of this clinical trial is to learn about the recommended dose of thermotherapy in addition to radiotherapy for patients with head and neck cancer. This recommended dose is the dose that is tolerable and does not give additional side effects.\n\nThe main question our study aims to answer is:\n\n\"What is the recommended dose of thermotherapy for patients with primary head and neck cancer treated with radiotherapy?\"\n\nParticipants will receive thermotherapy once a week in addition to the standard radiotherapy. Researchers will investigate if side effects occur during the treatment and until 6 months after the last treatment has been given.\n\nThe thermotherapy will be applied using a device that was made in Erasmus MC and allows for precise heating of the tumor and lymph nodes.",[83,84,27,85,86],"Head and Neck Cancer","Oropharyngeal Carcinoma","Laryngeal Cancer","Head and Neck Squamous Cell Carcinoma",[88,89,90,91,92,93],"Hyperthermia","Thermotherapy","Clinical Trial","Thermoradiotherapy","Phase 1 trial","Radiosensitization","2025-07-22",{"date":96,"type":36},"2025-07-25",{"date":98,"type":36},"2025-05-01",{"date":100,"type":21},"2028-10-31",{"name":102,"class":42},"Erasmus Medical Center",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":103},"100589709","phase-3-comparing-neoadjuvant-chemotherapy-combined-with-pd-1-inhibitor-versus-neoadjuvant-chemotherapy-in-locally-advanced-laryngeal-and-hypopharyngeal-carcinoma-100589709","NCT06957938","Comparing Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma","A Prospective, Multi-centered, Randomized Phase III Study to Compare Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Patients who have signed the informed consent form and are willing to complete the study according to the protocol.\n2. Age ≥18 years and ≤75 years.\n3. Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx.\n4. Locally advanced laryngeal or hypopharyngeal cancer that requires total laryngectomy and is amenable to total laryngectomy according to surgical assessment.\n5. At least one measurable lesion before treatment, which meets the criteria for \"measurable lesion\" according to RECIST 1.1 criteria.\n6. An expected survival of \\>3 months.\n7. ECOG performance status of 0-1.\n8. Adequate organ function, meeting the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Platelet count ≥100×10\\^9\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL;\n   4. Serum albumin ≥2.8 g\u002FdL;\n   5. Total bilirubin ≤1.5×ULN, ALT, AST, and\u002For ALP ≤3×ULN;\n   6. Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault, see Appendix III);\n   7. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients on stable doses of anticoagulant therapy, such as low-molecular-weight heparin or warfarin, with INR within the therapeutic range of the anticoagulant, are eligible).\n9. Patients with hepatitis B virus (HBV) infection, as well as inactive\u002Fasymptomatic HBV carriers, or those with chronic or active HBV, will be allowed to enroll if HBV DNA \\\u003C500 IU\u002FmL (or 2500 copies\u002FmL) at screening. Patients who are positive for hepatitis C antibody will be allowed to enroll if HCV-RNA is negative at screening.\n10. Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days before treatment. They must also agree to use an accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period, as well as for at least 3 months after the last dose of PD-1 inhibitor and at least 6 months after the last dose of chemotherapy.\n11. Male subjects who have not been sterilized must agree to use an accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period, as well as for at least 3 months after the last dose of PD-1 inhibitor and at least 6 months after the last dose of chemotherapy.\n\nExclusion Criteria:\n\n1. Patients who have been confirmed to have distant metastasis on imaging assessment before treatment.\n2. Patients who have previously received immune checkpoint inhibitor therapy.\n3. Patients who have previously received radiotherapy to the head and neck region.\n4. Patients who have had or currently have other malignancies (except for malignancies that have been cured and have been cancer-free for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer); if a patient has both hypopharyngeal cancer and esophageal cancer, and the esophageal lesion and hypopharyngeal lesion are anatomically non-adjacent, they should be diagnosed with multiple primary tumors and will not be eligible for enrollment.\n5. Uncontrolled cardiac symptoms or diseases, such as: a. NYHA Class II or higher heart failure; b. unstable angina; c. myocardial infarction within the past year; d. clinically significant supraventricular or ventricular arrhythmias that are not well controlled with medication.\n6. Patients who have received any of the following treatments:\n\n   1. Received any investigational drug within 4 weeks before the first dose of the study drug.\n   2. Enrolled in another clinical study concurrently, unless it is an observational (non-interventional) clinical study.\n   3. Require systemic treatment with corticosteroids (more than 10 mg prednisone equivalent per day) or other immunosuppressive agents within 2 weeks before the first dose of the study drug, except for corticosteroids used for local inflammation and prevention of allergies and nausea\u002Fvomiting. Other special circumstances should be discussed with the investigator. In the absence of active autoimmune disease, the use of inhaled or topical steroids and adrenal corticosteroid replacement at doses greater than 10 mg\u002Fday prednisone equivalent is permitted.\n   4. Received anti-tumor vaccines or live vaccines within 4 weeks before the first dose of the study drug (if the patient has received a COVID-19 vaccine, the interval between vaccination and treatment should be more than 2 weeks).\n   5. Underwent major surgery or had a severe injury within 4 weeks before the first dose of the study drug.\n7. Patients who have had a severe infection (CTCAE \\> Grade 2) within 4 weeks before the first dose of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging showing active pulmonary inflammation; symptoms and signs of infection within 4 weeks before the first dose of the study drug or requiring oral or intravenous antibiotic treatment.\n8. Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); however, this does not include autoimmune hypothyroidism treated with a stable dose of thyroid hormone replacement therapy; type 1 diabetes treated with a stable dose of insulin; vitiligo or childhood asthma\u002Fallergies that have healed and do not require any intervention in adulthood.\n9. Patients with a history of immunodeficiency, including positive HIV test results, or those with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation.\n10. Patients with a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with corticosteroids) or non-infectious pneumonia.\n11. Patients with active tuberculosis infection identified through history or CT scan, or those with a history of active tuberculosis infection within 1 year before enrollment, or those with a history of active tuberculosis infection more than 1 year ago that was not properly treated.\n12. Patients with active hepatitis B (HBV DNA ≥500 IU\u002FmL or 2500 copies\u002FmL) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).\n13. Patients with a known history of abuse of psychoactive drugs, alcoholism, or drug addiction.\n14. Pregnant or breastfeeding women.\n15. Patients who, in the investigator's judgment, have other factors that may force them to discontinue the study prematurely, such as having other serious diseases (including mental illnesses) requiring concurrent treatment, severely abnormal laboratory values, family or social factors, or conditions that may affect the patient's safety or the collection of trial data.",{"count":112,"type":21},168,[114],"PHASE3","Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear.\n\nThus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.",[117,27],"Laryngeal Carcinoma",[119,120,121,122,29,123,124,125,126,127,128,129,130,131],"Neoadjuvant chemotherapy","Induction chemotherapy","Immunotherapy","anti-PD-1 antibody","Tislelizumab","surgery","radiation","Locally advanced disease","Laryngeal preservation","Laryngeal cancer","Hypopharyngeal cancer","Head and neck cancer","Head and neck squamous cell carcinoma","NOT_YET_RECRUITING","2025-05-05",{"date":135,"type":36},"2025-05-08",{"date":137,"type":21},"2025-04-28",{"date":139,"type":21},"2031-05-01",{"name":141,"class":42},"Fudan University",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":103},"100314008","neck-dissection-vs-radiotherapy-for-cervical-metastases-in-advanced-hypopharyngeal-cancer-100314008","NCT03367884","Neck Dissection vs Radiotherapy for Cervical Metastases in Advanced Hypopharyngeal Cancer","Neck Dissection Versus Radiotherapy for Cervical Lymph Node Metastasis in Advanced Hypopharyngeal Carcinoma With Poor Response to Induction Chemotherapy : A Randomized Controlled Prospective Study","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document\n2. Age≥ 18 and≤ 75 years\n3. Histological\u002F cytological\u002F Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment\n4. Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter\n5. EPOG≤1,KPS≥ 70\n6. No contraindication of surgery and radiotherapy\n7. No serious disease history of the heart, liver, kidney, lung and other important organs\n8. Expected survival period≥ 12 months\n9. Good compliance\n\nExclusion Criteria:\n\n1. Inability to provide an informed consent\n2. Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)\n3. Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms\n4. The patient has received prior surgery or radiotherapy (except for biopsy)\n5. The patient has received chemotherapy or immunotherapy\n6. Pregnant or lactating women\n7. Other disease requiring simultaneous surgery or radiotherapy",{"count":150,"type":21},120,[54],"At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.",[27],[129,155,120,156,157],"Neck dissection","Cervical lymph node metastasis","definitive radiotherapy","2017-12-10",{"date":160,"type":36},"2017-12-12",{"date":162,"type":21},"2018-01-01",{"date":164,"type":21},"2028-01-01",{"name":166,"class":42},"Tianjin Medical University Cancer Institute and Hospital"]