[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head--neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head--neck-squamous-cell-carcinoma":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,68,80,104,131,155,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054288","diagnostic-performance-of-4d-dynamic-lafov-fdg-pet-acquisition-for-differentiation-of-residual-disease-and-post-radiation-inflammation-in-head-neck-scc-treated-by-radiotherapy-100054288",false,"NCT07417605","Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.","POLARIS","Inclusion Criteria:\n\n* Adult patient ≥ 18 years of age\n* Presenting with head and neck squamous cell carcinoma\n* Completed curative treatment with external radiation therapy\n* Eligible for dynamic LAFOV FDG-PET scan for therapeutic evaluation at 3 months\n* Having given consent for the end-of-treatment consultation\n\nExclusion Criteria:\n\n* Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent\n* Pregnancy or breastfeeding\n* History of treated upper gastrointestinal tract cancer\n* Other histology\n* Incomplete RTE treatment regimen\n* Refusal to participate","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","OBSERVATIONAL","This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.",[24],"Head & Neck Squamous Cell Carcinoma",[26,27,28,29],"4D dynamic analysis","post-radical inflammation","squamous cell carcinomas","FDG-PET LAFOV","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-04-13",{"date":38,"type":20},"2029-06-13",{"name":40,"class":41},"University Hospital, Brest","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100645121","phase-2-trilaciclib-combined-with-immunochemotherapy-for-rm-hnscc-100645121","NCT07679997","Trilaciclib Combined With Immunochemotherapy for R\u002FM HNSCC","A Prospective, Single-Arm, Phase II Trial of Trilaciclib Combined With Immunotherapy and Chemotherapy as First-Line Treatment for Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1.Age ≥18 and ≤75 years, male or female. 2.Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).\n\n  3.Recurrent and\u002For metastatic HNSCC not suitable for locoregional therapy. Patients with recurrent-only disease (without metastasis) must have previously received radiotherapy (either as adjuvant therapy after surgery or as treatment for locally advanced SCCHN) as \"locoregional therapy,\" and radiotherapy must have been completed more than 6 months prior to screening imaging.\n\n  4.At least one measurable lesion per RECIST 1.1 criteria. 5.Laboratory tests meeting the following criteria:\n  1. Hemoglobin ≥ 100 g\u002FL (female) \u002F 110 g\u002FL (male)\n  2. Absolute neutrophil count ≥ 2.0 × 10⁹\u002FL\n  3. Platelet count ≥ 100 × 10⁹\u002FL\n  4. Serum creatinine ≤ 15 mg\u002FL or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n  5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or ≤ 5 × ULN in patients with liver metastases\n  7. Albumin ≥ 30 g\u002FL 6.ECOG Performance Status score of 0 or 1. 7.Expected survival time ≥ 3 months. 8.No plans for conception or breastfeeding from 2 weeks before the start of study treatment until 3 months after the end of the study.\n\n     9.Ability to understand and willingness to sign the informed consent form.\n\n     Exclusion Criteria:\n* 1.Diagnosis of a malignancy other than HNSCC within 5 years before the first dose (except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n\n  2.Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV).\n\n  3.History of stroke or major cerebrovascular event within 6 months prior to enrollment.\n\n  4.QTcF interval \\>480 msec at screening, or \\>500 msec for patients with a ventricular pacemaker.\n\n  5.Prior hematopoietic stem cell or bone marrow transplantation. 6.Known hypersensitivity to the study drug or any of its components. 7.Any other condition for which the investigator deems the subject unsuitable for participation in this study.","75 Years",{"count":52,"type":20},32,"INTERVENTIONAL",[55],"PHASE2","This study is a prospective, single-arm, phase II clinical trial involving patients with advanced HNSCC receiving immunotherapy plus platinum-based dual-drug chemotherapy. It aims to evaluate the myeloprotective efficacy of administering trilaciclib prior to immunotherapy and platinum-based chemotherapy. The objective is to reduce the incidence of chemotherapy-induced myelosuppression (CIM) through pre-chemotherapy myeloprotection, thereby enabling patients to receive chemotherapy on schedule and at full dose. This approach is intended to ensure the efficacy of the chemotherapy regimen and ultimately achieve survival benefits for the patients.",[24],"NOT_YET_RECRUITING","2026-06-28",{"date":61,"type":34},"2026-07-01",{"date":63,"type":20},"2026-06-01",{"date":65,"type":20},"2027-09-30",{"name":67,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":69,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":71,"keywords":72,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":78,"locationsCount":79},"100625051",{"count":19,"type":20},[24],[26,27,28,29],"2026-04-21",{"date":75,"type":34},"2026-04-22",{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":53,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":79},"100627162","phase-3-postoperative-radiotherapy-combined-with-nimotuzumab-followed-by-benmelstobart-in-high-risk-patients-with-head-and-neck-squamous-cell-carcinoma-100627162","NCT07445048","Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \\> 70 years;② Renal insufficiency (creatinine clearance \\\u003C 50 mL\u002Fmin; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy \\> Grade 1;⑥ Patient refusal of chemotherapy.\n3. Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative\u002Funrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.\n4. Underwent radical surgery with at least one high-risk feature:\n\n   Extracapsular extension (ECE) of lymph node metastasis; Close margin (\\\u003C 1 mm) or positive margin;\n   * 4 metastatic lymph nodes, or multiple perineural invasions.\n5. No evidence of distant metastasis on imaging.\n6. Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV\u002Fp16 testing is required (testing may be waived if results are already available).\n7. Expected survival ≥ 6 months.\n8. ECOG performance status 0-1.\n9. Adequate hematologic function:\n\n   WBC ≥ 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL.\n10. Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin (calculated by Cockcroft-Gault formula):\n\n    Female: CrCl = (140 - Age) × Weight (kg) × 0.85 \u002F (72 × Scr (mg\u002FdL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 \u002F (72 × Scr (mg\u002FdL))\n11. Adequate hepatic function:\n\n    Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN.\n12. Women of childbearing potential: negative serum or urine pregnancy test within 14 days before enrollment, and agreement to use effective contraception during the study.Male subjects: use effective contraception from the start of treatment until 180 days after the last study drug administration.\n13. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.\n\nexclusion Criteria:\n\n1. Prior radiotherapy for head and neck cancer before enrollment.\n2. Prior treatment with similar immunological or targeted agents.\n3. Participation in another interventional clinical trial within 30 days prior to screening.\n4. Evidence of distant metastasis.\n5. History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary \u002F follicular), localized prostate cancer, and ductal carcinoma in situ.\n6. Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.).\n7. Known HIV infection, active viral hepatitis, or active tuberculosis.\n8. Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study.\n9. Hypersensitivity to any study drug or their components.\n10. Pregnancy (confirmed by serum or urine HCG test) or lactating women; subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment.\n11. Subjects considered inappropriate for study participation by the investigator.\n12. Subjects unwilling to participate in the study or unable to provide written informed consent.",{"count":88,"type":20},370,[90],"PHASE3","A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.\n\nThe primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.",[24,93,94],"Head & Neck Cancer","Postoperative Adjuvant Treatment","2026-04-14",{"date":97,"type":34},"2026-04-17",{"date":99,"type":34},"2026-03-04",{"date":101,"type":20},"2031-03-05",{"name":103,"class":41},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":53,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":79},"100631916","a-study-of-adaptive-radiotherapy-of-head-neck-cancer-using-daily-replanning-and-optimization-of-the-treatment-plan-100631916","NCT07506902","A Study of Adaptive Radiotherapy of Head-neck Cancer Using Daily Replanning and Optimization of the Treatment Plan.","DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.","DART-HN","Inclusion Criteria:\n\n* Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer Informed consent as required by law The patient cannot participate in conflicting protocols Stage I-IV (excluding T1-T2N0 carcinoma of the glottic larynx) ECOG\u002FWHO performance status 0-2\n\nExclusion Criteria:\n\nPatient with cancers of the glottic larynx (stage I\u002FII), skull base, sino-nasal area and unknown primary tumor.\n\nInability to attend full course of radiotherapy or follow-up visits in the outpatient clinic Distant metastasis Previous radiotherapy of the head and neck Previous surgery for the primary cancer with curative intent\n\n\\-",{"count":113,"type":20},40,[115],"NA","Radiotherapy of head-neck cancer is associated with significant side effects. Using daily online adaptive radiotherapy to account for the changing anatomy, radiation to organs at risk can be lowered. We will investigate whether this is feasible and associated with a reduction in the risk of toxicity.",[24],[119,120,121],"Head and neck cancer","Adaptive radiotherapy","Online adaptive radiotherapy","2026-03-26",{"date":124,"type":34},"2026-04-02",{"date":126,"type":34},"2023-11-21",{"date":128,"type":20},"2028-12",{"name":130,"class":41},"Rigshospitalet, Denmark",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":53,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":79},"100630255","phase-2-effect-of-postbiotics-on-microbiota-and-systemic-immunomodulation-of-pembrolizumab-as-first-line-therapy-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-rm-hnscc-100630255","NCT07485296","Effect of Postbiotics on Microbiota and Systemic Immunomodulation of Pembrolizumab as First-Line Therapy in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)","A Phase II, Randomized, Double-blind, Placebo Controlled, Multicenter Pilot Study to Evaluate the Effect of Postbiotics on Microbiota and Systemic Immunomodulation of Pembrolizumab as First Line Standard of Care in Patients With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)","POST-BIO","-Inclusion Criteria\n\n1. Be willing and able to provide informed consent for the trial and its procedure;\n2. Histological confirmation of HNSCC;\n3. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) HNSCC;\n4. For oropharyngeal cancers, known IHC p16+ and\u002For ISH HPV status;\n5. Positive PD-L1 Combined Proportionate Score (CPS);\n6. Presence of neoplastic lesion deemed safely accessible for tumor biopsy by the investigator;\n7. No prior systemic therapy for RM HNSCC;\n8. Eligible to receive pembrolizumab as the standard of care\n9. ECOG Performance Status ≤ 2;\n10. Measurable disease as per RECIST 1.1;\n11. Males and females, ages ≥18;\n12. Adequate renal function defined as calculated creatinine clearance ≥30 milliliters per minute (mL\u002Fmin) per the Cockcroft and Gault formula or Serum creatinine \\\u003C 1.5 x upper limit of normal (ULN);\n13. Adequate liver function defined by AST or ALT \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases are present), and total bilirubin \\\u003C 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin up to 3.0 mg\u002FdL);\n14. Adequate bone marrow function defined by any of the following laboratory test findings: - WBC \\> 2,000\u002Fmm3, Neutrophils \\> 1,500\u002Fmm3, Platelets \\> 100,000\u002Fmm3;\n15. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;\n16. Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 6.3 and 6.4 - Contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n17. Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.3 and 6.4 - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; 18.\n\nWillingness to provide blood, buccal swab samples, stool samples and tissue (if deemed safe by the investigator) for translational research.\n\n\\- Exclusion Criteria\n\n1. Presence of untreated brain metastases. Patients with treated brain metastases must be stable for 4 weeks after completion of treatment and have documented stability on pre-study imaging. Patients must have no clinical symptoms from brain metastases and have no requirement for systemic corticosteroids amounting to \\>10 mg\u002Fday of prednisone or its equivalent for at least 2 weeks prior to first dose of study drug. Patients with known leptomeningeal metastases are excluded, even if treated.\n2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n3. Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.\n4. Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n5. Current use, or intent to use, probiotics, yogurt or bacterial fortified foods during the period of treatment.\n6. Any condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n7. Uncontrolled adrenal insufficiency.\n8. Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.\n9. Not recovered to ≤ Grade 1 toxicities related to any prior therapy before administration of study drug.\n10. Women who are pregnant or breastfeeding.\n11. History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry\n12. Any of the following laboratory test findings:\n\n    * WBC \\\u003C 2,000\u002Fmm3\n    * Neutrophils \\\u003C 1,500\u002Fmm3\n    * Platelets \\\u003C 100,000\u002Fmm3\n    * AST or ALT \\> 3 x ULN (\\> 5 x ULN if liver metastases are present)\n    * Total bilirubin \\> 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin 3.0 mg\u002FdL)\n    * Calculated creatinine clearance \\\u003C30 millimeters per minute (mL\u002Fmin) per the Cockcroft and Gault formula or serum creatinine \\>1.5 x upper limit of normal (ULN)\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n14. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n15. Has a known history of active TB (Bacillus Tuberculosis)\n16. Has previously received an organ transplant\n17. Has previously received bone marrow transplantation\n18. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.",{"count":140,"type":20},45,[55],"phase II, randomized, double-blind, placebo controlled, non pharmacological clinical trial that aims to determine the effect of postbiotics Postbiotix-HLA™ on immuno-related adverse events (irAEs) in patients with recurrent\u002Fmetastatic head and neck squamous cell carcinoma (RM HNSCC) treated with in first line pembrolizumab as standard of care (SoC).\n\nThe selected patient population will be randomised to receive the postbiotics Postbiotix-HLA™ or placebo for 4 cycles while in treatment with pembrolizumab as per clinical practice.",[24],[145],"recurrent\u002Fmetastatic head and neck squamous cell carcinoma (RM HNSCC)","2026-03-17",{"date":148,"type":34},"2026-03-20",{"date":150,"type":34},"2026-01-27",{"date":152,"type":20},"2032-12",{"name":154,"class":41},"Gruppo Oncologico del Nord-Ovest",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":79},"100627445","impact-of-early-response-to-first-line-anti-pd-1-monotherapy-in-patients-with-recurrent-andor-metastatic-rm-head-and-neck-squamous-cell-carcinoma-assessed-by-18f-fdg-petct-100627445","NCT07448727","Impact of Early Response to First-line Anti-PD-1 Monotherapy in Patients With Recurrent and\u002For Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma, Assessed by 18F-FDG PET\u002FCT","Prospective Observational Study On The Impact Of Early Response To First-line Anti-PD-1 Therapy In Patients With Recurrent And\u002FOr Metastatic (R\u002FM) Head And Neck Squamous Cell Carcinoma, Assessed By 18F-FDG PET\u002FCT","PEMBRO-PET","Inclusion Criteria:\n\n* Histological diagnosis of recurrent and\u002For metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment\n* CPS PD-L1 \\>=1\n\nExclusion Criteria:\n\n* Any controindication to immune checkpoint inhibitors",{"count":164,"type":20},25,"This study aims to evaluate the role of early response assessment by 18F-FDG PET\u002FCT in patients with recurrent and\u002For metastatic (R\u002FM) head and neck squamous cell carcinoma with PD-L1 CPS \\>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.",[93,24],"2026-02-28",{"date":99,"type":34},{"date":170,"type":34},"2024-11-20",{"date":172,"type":20},"2027-12",{"name":174,"class":41},"University of Rome Tor Vergata",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":53,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":79},"100618565","phase-3-compare-radiotherapy-plus-nimotuzumab-versus-radiotherapy-alone-in-platinum-ineligible-patients-with-locoregionally-advanced-head-and-neck-squamous-cell-carcinoma-100618565","NCT07333274","Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma","An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n* Eligible subjects must meet all of the following:\n\n  * Age ≥18 years.\n  * Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).\n  * Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \\[T3-4 N0-3 M0, or T1-2 N2-3 M0\\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).\n  * Suitable for definitive radiotherapy with curative intent.\n  * At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:\n* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;\n* ECOG Performance Status \\>2 (if this criterion is met, the ECOG criterion listed below may be waived);\n* Renal dysfunction: creatinine clearance (CrCl) \\\u003C50 mL\u002Fmin (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);\n* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);\n* Peripheral neuropathy \\> Grade 1;\n* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.\n\n  * Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV\u002Fp16 testing if feasible (no need to retest if previously tested).\n  * ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).\n  * At least one measurable lesion per RECIST 1.1.\n  * Expected survival ≥6 months.\n  * Adequate hematologic function: WBC ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n  * Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault):\n* Female CrCl = (140 - age) × weight (kg) × 0.85 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n* Male CrCl = (140 - age) × weight (kg) × 1.00 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n\n  * Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n  * Voluntary participation: signed written informed consent and ability to comply with visits and procedures.\n\nExclusion Criteria:\n\n* Any of the following excludes enrollment:\n\n  * Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.\n  * Participation in another interventional clinical trial within 30 days prior to screening.\n  * History of other malignancy (except cured basal cell carcinoma of the skin).\n  * History of primary immunodeficiency.\n  * Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).\n  * Known HIV infection, or active viral hepatitis or active tuberculosis.\n  * Major surgery within 90 days before first study treatment, or planned surgery during the study.\n  * Known allergy to nimotuzumab or its excipients.\n  * Deemed unsuitable to participate by the investigator.\n  * Unwilling or unable to sign informed consent.\n  * Receipt of a live vaccine within 30 days before first dose.",{"count":183,"type":20},335,[90],"This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),",[24,93],[188,189,190,191],"Nimotuzumab","Radiotherapy","locoregionally advanced head and neck squamous cell carcinoma","LA-HNSCC","2025-12-30",{"date":194,"type":34},"2026-01-12",{"date":196,"type":20},"2026-01-05",{"date":198,"type":20},"2030-01-05",{"name":200,"class":41},"Shandong Cancer Hospital and Institute"]