[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-cell-carcinoma-head-and-neck-cancer-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-cell-carcinoma-head-and-neck-cancer-hnscc":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,59,92,118,143,164,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371",false,"NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.",[25,26,27,28,29,30,31,32,33,34,35],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[37,38,39,40,41,42,43,44,45],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-06-26",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":19},"2026-07",{"date":54,"type":19},"2031-04",{"name":56,"class":57},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":58},"100644619","integrated-early-care-for-head--neck-cancer-100644619","NCT07671573","Integrated Early-CARE for Head & Neck Cancer.","Randomized Multicenter Clinical Trial of Early Integration of Palliative Care With Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients With Locally Advanced Unresectable Head and Neck Cancer.","i-CARE-HN","Inclusion Criteria:\n\nEach patient must fulfil all of the following criteria:\n\n1. Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis;\n2. Age ≥18 years;\n3. ECOG performance status 0-2;\n4. Adequate organ function: haemoglobin ≥9 g\u002FdL; neutrophils ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN;\n5. Signed informed consent by the participant.\n\nExclusion Criteria:\n\nEach patient will be excluded if they meet any of the following criteria:\n\n1. ECOG performance status 3-4;\n2. Previous follow-up by specialised palliative care;\n3. Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;\n4. Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);\n5. Severe comorbidities: decompensated cardiovascular disease (NYHA class III\u002FIV heart failure, recent myocardial infarction), severe COPD (FEV₁ \\\u003C50% predicted), renal insufficiency (eGFR \\\u003C30 mL\u002Fmin), hepatic insufficiency (Child-Pugh B\u002FC);\n6. Laboratory values: neutrophils \\\u003C1.5×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL, haemoglobin \\\u003C9 g\u002FdL, creatinine \\>1.5×ULN;\n7. Diagnosis of dementia;\n8. Participation in another clinical trial.",{"count":68,"type":19},64,[70],"NA","In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.\n\nThe i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.\n\nIn the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.\n\nThis study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg\u002Fm² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.",[73,74,30],"Head & Neck Cancer","Locally Advanced Head and Neck Cancer",[76,77,78,79,80,81,82],"chemoradiotherapy","Cancer","Palliative care","Locally advanced Head and neck cancer","Squamous Cell Carcinoma of the Head and Neck","Edmonton Symptom Assessment System (ESAS)","Head and neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-25",{"date":47,"type":50},{"date":87,"type":19},"2026-10-01",{"date":89,"type":19},"2028-03-31",{"name":91,"class":57},"Portuguese Oncology Institute, Coimbra",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":58},"100613245","phase-3-study-comparing-ivonescimab-alone-or-ivonescimab-in-combination-with-ligufalimab-versus-pembrolizumab-for-the-treatment-of-scchn-100613245","NCT07264075","Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN","A Randomized, Open-label, Multicenter, Phase 3 Trial of Ivonescimab Alone or With Ligufalimab Versus Pembrolizumab in First-line Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","ILLUMINE","Inclusion Criteria:\n\n1. Patient capable of voluntary giving her\u002Fhis written informed consent.\n2. Age ≥ 18 and \\\u003C 80 years old at the time of enrolment.\n3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.\n4. Expected survival ≥ 6 months at randomization.\n5. Patient is histologically and\u002For cytologically confirmed to have r\u002Fm HNSCC (according to the International Union Against Cancer and the American Joint Committee on Cancer 8th edition staging system) with a primary tumour initially or currently located in the oral cavity, oropharynx, hypopharynx, or larynx.\n6. HPV status test results based on tumour tissue samples must be obtained prior to randomization for patients with oropharyngeal cancer.\n7. No prior systemic anti-tumour therapy for R\u002FM HNSCC. Note: Patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy with curative intent for non-metastatic disease, radiotherapy, or radical radiotherapy in combination with chemotherapy or cetuximab\u002FEGFR based therapy for locally advanced disease are eligible for this study if disease progression occurs \\> 6 months after the end of the last treatment.\n8. At least one measurable lesion according to RECIST v1.1, or measurable lesion with clear radiographic progression after local therapy, and the lesion must be suitable for repeated accurate measurements (see Appendix 3).\n9. Tumours must be PD-L1 positive (CPS ≥ 1) as confirmed by CE-IVD immunohistochemistry assay based on local assessment with any assay validated for HNSCC in a laboratory compliant with National provisions. The measurement of PD-L1 protein expression can be performed based on archival tissue sample before the diagnosis of R\u002FM tumour or based on tissue sample obtained after the diagnosis of a R\u002FM tumour.\n10. Good organ function is determined by the following requirements:\n\n    a.Haematology (satisfactory laboratory test results obtained during the screening period, and no blood components used within 14 days of cell growth factor supportive therapy): i.Absolute neutrophil value (ANC) ≥ 1.5×109\u002FL (1,500\u002Fmm3) ii.Platelet count ≥ 100×109\u002FL (100,000\u002Fmm3) iii.Haemoglobin ≥ 10 g\u002FdL b.Kidneys: i.Calculated creatinine clearance (Appendix 4) ≥ 50 mL\u002Fmin ii.Urine protein ≤ 2+ or 24 hours (h) urine protein quantification \\\u003C 1.0 g c.Liver: i.Serum total bilirubin ≤ 1.5× upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, ≤ 3 × ULN ii.AST and ALT ≤ 2.5×ULN; For patients with liver metastases, AST and ALT ≤ 5×ULN iii.Serum albumin ≥ 28 g\u002FL d.Coagulation function: International normalized ratio (INR) and\u002For activated partial thromboplastin time (APTT) ≤ 1.5× ULN. This applies only to patients who are not on therapeutic anti- coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n\nExclusion Criteria:\n\n1. Primary tumour site (any histology) of nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid glands, skin, or unknown primary site of tissue origin.\n2. Patient with malignancies other than HNSCC within 3 years prior to enrolment. Patients with other tumours that have been cured through local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded.\n3. Concurrent enrolment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study; Received study treatment within 4 weeks prior to randomization.\n4. Prior treatment with systemic anti-angiogenic drugs.\n5. Previous head and neck re-irradiation for recurrent\u002Fmetastatic disease\n6. Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1 antibody, anti- CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, anti-CD47, anti-SIRPα, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment that targets tumour immunity including therapeutic tumour vaccine, and other adjuvant\u002Fneoadjuvant anti-PD-1 based therapy.\n7. Patients with ulcers on the skin surface related to the current cancer during the screening period, superficial or protruding skin lesions with excessive surface tension and a greater risk of ulceration, or other patients with a greater risk of ulceration as assessed by the investigator. Patients with recent tracheostomy involving the tumour which are at risk of bleeding.\n8. Imaging during the screening period shows that the tumour invades\u002Finfiltrates the surrounding important organs (such as trachea, oesophagus, and based on investigator assessment ofbleeding risk) and\u002For large blood vessels in the neck (such as subclavian artery, common internal and\u002For external carotid artery, etc.) or if the investigator judges that entering the study might cause a potential risk of bleeding.\n9. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, or leptomeningeal disease.\n10. Received curative head and neck radiotherapy within 6 months prior to randomization. Palliative local treatment for non-head and neck areas carried out within 3 weeks before randomization; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumour necrosis factor, etc.) within 2 weeks prior to randomization, excluding IL-11 for the treatment of thrombocytopenia.\n11. Presence of active autoimmune disease requiring systemic therapy (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to randomization. Alternative therapies (e.g., thyroxine, insulin, or those targeting the adrenal glands or pituitary) and physiologic corticosteroid replacement therapy for pituitary insufficiency are not considered systemic treatment.\n12. History of immunodeficiency; Those who have history of positive test for HIV antibodies; Current long-term use of systemic corticosteroids or other immunosuppressants is excluded.\n13. Previous or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current presence of lung diseases including but not limited to the following: pneumoconiosis, silicosis, drug-related pneumonia, pulmonary diseases with severe impairment of lung function, etc.\n14. Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active non-severe infection that has received systemic anti-infective therapy within 2 weeks prior to randomization.","80 Years",{"count":102,"type":19},780,[104],"PHASE3","This is a randomized, open-label, active-comparator-controlled, multi-regional, three-arm, phase 3 study comparing the efficacy and safety of ivonescimab in combination with ligufalimab to pembrolizumab and of ivonescimab alone to pembrolizumab as first-line treatment in patients with recurrent or metastatic (R\u002FM) PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).\n\nThe objective of this study is to improve first-line survival in patients with recurrent or metastatic PD-L1-positive HNSCC (CPS ≥ 1). Overall survival (OS) was chosen as the primary endpoint.\n\nPatients will receive the following treatment regimens in accordance with the study treatment plan until disease progression, death, intolerable toxicity, or the occurrence of another protocol-specified treatment discontinuation criterion, whichever occurs first.\n\n* ARM A: Ivonescimab (10 mg\u002Fkg iv, 60 min ± 10 min infusion, Q3W)\n* ARM B: Ivonescimab (10 mg\u002Fkg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg\u002Fkg iv, 120 min ± 15 min infusion, Q3W).\n* ARM C (control arm): Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). The total duration of treatment is up to 24 months",[30],[108],"first-line recurrent and\u002For metastatic","2026-05-18",{"date":111,"type":50},"2026-05-20",{"date":113,"type":50},"2026-05-05",{"date":115,"type":19},"2030-05",{"name":117,"class":57},"Groupe Oncologie Radiotherapie Tete et Cou",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":20,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":58},"100604414","phase-2-intraoperative-molecular-imaging-using-icg-for-head-and-neck-tumors-100604414","NCT07149207","Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors","Inclusion Criteria:\n\n1. Adult subjects at least 18 years of age.\n2. Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.\n3. Good operative candidate as determined by the treating physician and\u002For multidisciplinary team.\n4. Subject capable of giving informed consent and participating in the process of consent.\n5. A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and\u002For implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.\n2. A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:\n\n   1. they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or\n   2. they have had a hysterectomy.\n3. Known allergy to iodides or shellfish.\n4. Inadequate organ function at time of screening as defined below:\n\n   a. Hepatic\n   1. Total bilirubin \\>2 x IULN. Participants with a history of Gilbert's disease must have total bilirubin \\\u003C3mg\u002FdL.\n   2. AST (SGOT) and ALT (SPGT) \\>3 x IULN.\n5. Currently incarcerated individuals",{"count":125,"type":19},30,[127],"PHASE2","This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.",[30,130],"Margin Assessment",[77,132,40,133],"surgical margins","mucosal squamous cell cancer","2026-05-11",{"date":136,"type":50},"2026-05-12",{"date":138,"type":50},"2026-05-04",{"date":140,"type":19},"2029-04-07",{"name":142,"class":57},"Medical University of South Carolina",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":100,"enrollmentInfo":151,"targetDuration":4,"studyType":20,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":58},"100639281","phase-2-trial-evaluating-hypo-fractionated-accelerated-versus-conventional-fractionated-adjuvant-rt-in-head--neck-malignancies-100639281","NCT07573956","Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies","The HYPCON 3 Trial A Phase II\u002FIII Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies","Radiotherapy","Inclusion Criteria:\n\n* Patients with pT1-4 squamous cell carcinoma of oral cavity\u002F oropharynx\u002F larynx\u002F hypopharynx with any of the intermediate risk features:\n\n  * Positive lymph node (s)\n  * Perineural invasion\n  * Lympho-vascular invasion\n  * Close margins\n* Age 18-80yrs\n* ECOG performance status 0-1at time of surgery\n* Informed consent\n* Available FOR long term follow-up\n\nExclusion Criteria:\n\n* High risk factors following resection: positive-margin(s)and\u002For extra nodal extension (ENE)\n* pT1-2disease and no high-risk features (LVSI, PNI, Close margins,pN0)\n* Patients receiving Neo-adjuvant or concurrent Chemotherapy\n* Non-Squamous Histology\n* Distant metastasis\n* Synchronous or second primary malignancy outside of the oropharynx, oral cavity, larynx and hypopharynx\n* Pregnant females or nursing mothers due to the probability of congenital anomalies and potential of this regimen to harm nursing infants.\n* Prior Radiotherapy to head and neck region",{"count":152,"type":19},369,[127,104],"Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)",[30],{"date":157,"type":50},"2026-05-07",{"date":159,"type":50},"2026-02-10",{"date":161,"type":19},"2028-12-30",{"name":163,"class":57},"All India Institute of Medical Sciences",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":58},"100562658","tumor-informed-ctdna-testing-for-mrd-following-treatment-of-squamous-cell-carcinoma-100562658","NCT06606028","Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma","Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.\n2. Participants must be age \\>=18 years.\n3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.\n4. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1\\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).",{"count":172,"type":19},250,"OBSERVATIONAL","This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.",[176,30,177,178],"Squamous Cell Carcinoma of Head and Neck","Squamous Cell Carcinoma of Skin","Cutaneous Squamous Cell Carcinoma (CSCC)",[180],"ctDNA","2025-12-04",{"date":183,"type":50},"2025-12-12",{"date":185,"type":50},"2024-10-09",{"date":187,"type":19},"2029-12-30",{"name":189,"class":57},"University of California, San Francisco",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":58},"100603057","immune-response-in-cervical-lymph-nodes-of-patients-with-head-and-neck-cancer-100603057","NCT07131566","Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer","Inclusion Criteria:\n\n1. a diagnosis of primary HNSCC,\n2. tumor excision combined with a sentinel node-assisted elective neck dissection or sentinel node biopsy alone performed at Karolinska University Hospital, Stockholm, Sweden\n3. willingness to participate in the study.\n\nExclusion Criteria:\n\n1. systematic autoimmune diseases\n2. synchronous or previous second malignancies or hemo-lymphopoietic malignancies\n3. any other acute or chronic condition that could influence the immunological environment in the lymph nodes.",{"count":197,"type":19},500,"Objective:\n\nThe aim of this study is to characterize the inflammatory response in patients with head and neck cancer. More specifically, the study intend to investigate inflammatory and genetic differences between the primary tumor, the sentinel lymph node, and other regional lymph nodes. The investigator also aim to assess how the immunological and genetic responses differ in lymph nodes with and without metastases.\n\nTo enable the detection of metastases in lymph nodes containing very few cancer cells, the investigator are developing a method to identify tumor cells using flow cytometry. Additionally, both tumor tissue and lymph nodes will undergo in vitro testing of checkpoint blockade therapy, a relatively new form of cancer immunotherapy.\n\nMethods:\n\nBiopsies from the primary tumor will be used to assess local inflammation. Fine-needle aspirates and dissected lymph node tissue will be analyzed to study inflammatory and genetic responses, as well as to detect tumor cells within these nodes. Blood samples from patients with head and neck cancer will be analyzed for inflammatory mediators.\n\nLymph nodes from patients without cancer will be collected during benign neck surgeries. Immunological and genetic parameters from these control lymph nodes will be compared to those from the cancer patients to identify disease-specific patterns.",[30],"2025-08-12",{"date":202,"type":50},"2025-08-20",{"date":204,"type":50},"2025-06-01",{"date":206,"type":19},"2036-03",{"name":208,"class":57},"Lars Olaf Cardell"]