[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypopharyngeal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypopharyngeal-cancer":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,61,74,159,189,211,241],{"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":26,"conditions":27,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[28,29,30,31,32,33,34,35,36,37,38,39],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[41,42,43,44,45,46,47],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":21},"2026-07-16",{"date":56,"type":21},"2037-10-01",{"name":58,"class":59},"National Cancer Institute (NCI)","NIH",1,{"id":62,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":26,"conditions":65,"keywords":66,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":60},"100643883",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39],[41,42,43,44,45,46,47],"2026-07-01",{"date":69,"type":52},"2026-07-02",{"date":71,"type":21},"2026-07-07",{"date":56,"type":21},{"name":58,"class":59},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":137,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":158},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":85,"type":21},999999,"80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,38,111,112,113,33,114,115,116,117,118,119,120,36,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[90,91,138,139,140,141,142,143,144,145,125,146,135,136],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":150,"type":52},"2026-06-29",{"date":152,"type":52},"2013-11-01",{"date":154,"type":21},"2099-12",{"name":156,"class":157},"University of Nebraska","OTHER",42,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":167,"enrollmentInfo":168,"targetDuration":170,"studyType":87,"phases":4,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":60},"100633888","a-machine-learning-based-risk-prediction-model-for-head-and-neck-cancerous-lesions-100633888","NCT07532538","A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions","A Machine Learning-Based Risk Prediction Model for Head and Neck Cancerous Lesions: A Multidimensional Feature Study Integrating Demographics and Clinical Symptomatology","ML-HNC-Risk","Inclusion Criteria:\n\nAge ≥ 18 years old. Patients with complete clinical data information and laryngoscopic images.\n\nExclusion Criteria:\n\nRefusal to sign the informed consent form. Incomplete clinical data. Known diagnosis of other head and neck malignancies (thyroid cancer, malignant parotid tumors, etc.","100 Years",{"count":169,"type":21},3000,"6 Months","This study aims to develop and validate a clinical prediction model for the risk of head and neck cancerous lesions using deep learning combined with AI algorithms, based on multi-center clinical data.",[33,114,28],[174,175,176,177,178,179],"Head and neck malignant lesions","Hypopharyngeal cancer","Laryngeal cancer","AI","machine learning","AI-assisted diagnosis","2026-04-12",{"date":182,"type":52},"2026-04-16",{"date":184,"type":21},"2026-04-30",{"date":186,"type":21},"2030-11-30",{"name":188,"class":157},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100507951","the-voice-as-a-tool-to-detect-recurrence-of-laryngeal-and-hypopharyngeal-cancer-100507951","NCT05894070","The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer","The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study","VoiceDetect","Inclusion Criteria:\n\n1. Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical\u002Fradiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) \u002F Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC \u002F TNM 8th ed.).\n2. ≥ 18 years of age.\n3. Treatment with curative intent, regardless of treatment modality (mono- or multimodal).\n\n   Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.\n4. Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).\n\n   Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.\n5. Informed consent as documented by signature.\n\nExclusion Criteria:\n\n1. Total laryngectomy as primary therapy.\n2. Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence\u002Fprogression, or recurrence before enrolment.\n\n   Excepted: Patients with synchronous laryngeal\u002Fhypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.\n3. Any local, regional, and systemic tumor persistence\u002Fprogression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before\u002Fafter the diagnosis of LSCC\u002FHPSCC) non-laryngeal\u002F-hypopharyngeal malignant tumors within 6 months before enrolment.\n\n   Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and\u002For basal cell carcinoma of the skin and\u002For non-head and neck progredient or recurrent Tis.\n4. Any previously treated LSCC\u002FHPSCC or treated second primary malignancies of the larynx or hypopharynx before the diagnosis and treatment of the investigated LSCC\u002FHPSCC (= index tumor).\n5. Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.\n6. Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).",{"count":198,"type":21},100,"The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx\u002Fhypopharynx for a minimal period of 6 months from all laryngeal\u002Fhypopharyngeal squamous cell carcinoma (LSCC\u002FHPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.",[114,33],"2025-07-24",{"date":203,"type":52},"2025-07-29",{"date":205,"type":52},"2023-08-02",{"date":207,"type":21},"2026-06-30",{"name":209,"class":157},"Insel Gruppe AG, University Hospital Bern",2,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":60},"100519137","phase-2-neoadjuvant-chemoimmunotherapy-followed-by-radiation-or-organ-preservation-surgery-in-laryngealhypopharyngeal-cancer-100519137","NCT06039631","Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal\u002FHypopharyngeal Cancer","Neoadjuvant Immunotherapy And Chemotherapy Followed By Concurrent Chemoradiation Or Organ Preservation Surgery In Locally Advanced Laryngeal Cancer And Hypopharyngeal Cancer","Inclusion Criteria:\n\n1. Signing of the informed consent form and willingness to comply with the study protocol.\n2. Age ≥18 and ≤75 years.\n3. Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.\n4. Locally advanced laryngeal\u002Fhypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).\n5. Presence of at least one measurable lesion before treatment, in accordance with RECIST 1.1 criteria for \"measurable lesions.\"\n6. Patients who have received neoadjuvant immunotherapy combined with chemotherapy and have achieved a partial response (PR) in the primary lesion according to RECIST 1.1 criteria and are suitable candidates for organ preservation surgery.\n7. Expected survival of more than 3 months.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n9. Good organ function, meeting the following criteria:\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× upper limit of normal (ULN), ALT, AST, and\u002For ALP ≤3× ULN.\n   6. Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula, see Appendix III).\n   7. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5× ULN (patients on stable doses of anticoagulation with agents like low molecular weight heparin or warfarin, and INR within the expected therapeutic range, may be included).\n10. Patients with hepatitis B virus (HBV) infection, inactive\u002Fasymptomatic HBV carriers, or patients with chronic or active HBV infection with HBV DNA \\\u003C500 IU\u002FmL (or 2500 copies\u002FmL) at screening will be allowed to participate. Patients positive for hepatitis C antibodies, if HCV-RNA is negative at screening, will be allowed to participate.\n11. Females of childbearing potential must have a negative pregnancy test result in urine or serum ≤7 days before treatment initiation. They must use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.\n12. Non-sterilized male participants must be willing to use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.\n\nExclusion Criteria:\n\n1. History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.\n2. Pre-existing tracheostomy due to laryngeal dysfunction before treatment.\n3. History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.\n4. Uncontrolled clinical cardiac symptoms or diseases, including:\n\n   1. NYHA Class II or higher heart failure.\n   2. Unstable angina.\n   3. Myocardial infarction within the past year.\n   4. Clinically significant ventricular or supraventricular arrhythmias requiring clinical intervention.\n5. Previous treatment with any of the following:\n\n   1. Use of any investigational drug within 4 weeks prior to the first dose of study treatment.\n   2. Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial.\n   3. Requiring systemic treatment with corticosteroids (daily dose \\>10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of study treatment, excluding corticosteroids for localized inflammation or prophylaxis against allergies or nausea\u002Fvomiting. Other specific circumstances should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a dose of \\>10 mg\u002Fday prednisone or equivalent are allowed.\n   4. Vaccination with anti-tumor vaccines or administration of live vaccines within 4 weeks prior to the first dose of study treatment (for patients who received COVID-19 vaccine, a 2-week interval is required).\n   5. Major surgery within 4 weeks before the first dose of study treatment or presence of severe trauma.\n6. Failure to recover to ≤ Grade 1 toxicity per CTCAE (except for alopecia and residual neuropathy related to prior platinum therapy) from previous cancer therapy or from any other cause unrelated to study\u002Fenrollment criteria.\n7. Experience of severe infections (CTCAE \\> Grade 2) within 4 weeks before the first dose of study treatment, such as severe pneumonia requiring hospitalization, sepsis, or complicated infections. Baseline chest imaging indicating active pulmonary inflammation, presence of symptoms and signs of infection within 4 weeks before the first dose of study treatment, or requirement for oral or intravenous antibiotics to treat infection are exclusion criteria.\n8. Active autoimmune disease or history of autoimmune disease, such as interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes. However, stable dose of thyroid replacement therapy for autoimmune-mediated hypothyroidism is allowed. Stable dose of insulin for type I diabetes is allowed. Patients with vitiligo or childhood-onset asthma\u002Fallergies requiring no intervention as adults are allowed.\n9. History of immune deficiency, including HIV positive test results, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n10. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids), non-infectious pneumonitis.\n11. Active tuberculosis infection found through medical history or CT scan, or presence of active tuberculosis infection within the past year prior to enrollment, or history of active tuberculosis infection more than 1 year ago but not formally treated.\n12. Presence of active hepatitis B (HBV DNA ≥500 IU\u002FmL or 2500 copies\u002FmL) or hepatitis C (HCV-RNA positive with HCV-RNA levels above the lower limit of detection of the assay) infection＊.\n13. Known history of substance abuse, alcohol abuse, or drug addiction.\n14. Pregnant or breastfeeding women.\n15. Other factors, as judged by the investigator, that may interfere with the participant's ability to comply with the study requirements or that may jeopardize the safety of the participant or the quality of the study data, including the presence of other severe diseases (including mental illness) requiring concurrent treatment, severe abnormal laboratory values, family or social factors, which might affect participant safety or data collection.\n\n    * For participants who are HBsAg-positive and either HBV DNA-negative or with HBV DNA \\\u003C500 IU\u002FmL or 2500 copies\u002FmL, after receiving stable antiviral treatment, they may be included in this trial (treatment should be ongoing for \\>2 weeks before enrollment, and continued for 6 months after the last dose of study treatment).","75 Years",{"count":220,"type":21},82,[25],"In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.\n\nPast approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.\n\nAgainst this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.",[224,33],"Larynx Cancer",[226,227,228,229,230,231],"organ preservation","PD-1 inhibitor","Immunotherapy","Neoadjuvant chemotherapy","Induction chemotherapy","larynx presrvation surgery","2023-09-09",{"date":234,"type":52},"2023-09-15",{"date":236,"type":52},"2023-08-22",{"date":238,"type":21},"2029-09-01",{"name":240,"class":157},"Fudan University",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100468091","immune-biomarker-study-for-head-and-neck-cancer-100468091","NCT05375266","Immune Biomarker Study for Head and Neck Cancer","ImmunBio-KHT","Inclusion Criteria:\n\n* Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)\n* Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)\n* Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)\n* Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes\n* Age ≥ 18 years\n* Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastases and \u002F or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)\n* Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment\n* Present drug abuse\n* Patients who are unable or unwilling to behave and receive treatment according to protocol\n* Patients who are legally patronized\n* Patients who are not eligible for participation in the study due to language barrier",{"count":249,"type":21},1100,"The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.",[28,116,118,33,114],[253,228],"Immunologic markers","2023-05-16",{"date":256,"type":52},"2023-05-17",{"date":258,"type":52},"2022-05-16",{"date":260,"type":21},"2027-03-31",{"name":262,"class":157},"University of Erlangen-Nürnberg Medical School",3]