[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-head-and-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-head-and-neck-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,42,167,215,246,272,294,318,345,372,395,417,438,464,485],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100526063","phase-3-a-global-study-of-volrustomig-medi5752-for-participants-with-unresected-locally-advanced-head-and-neck-squamous-cell-carcinoma-following-definitive-concurrent-chemoradiotherapy-100526063",false,"NCT06129864","A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy","A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)","eVOLVE-HNSCC","Inclusion Criteria:\n\n* Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).\n* Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).\n* Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \\>1 primary tumors are not eligible for the study.\n* Participants with any of the following:\n\n  1. LA-HNSCC that was resected before definitive cCRT\n  2. LA-HNSCC that was treated and is recurrent at the time of screening\n* Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.","ALL","18 Years","130 Years",{"count":21,"type":22},1145,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).",[28],"Locally Advanced Head and Neck Squamous Cell Carcinoma","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-24","ACTUAL",{"date":35,"type":33},"2023-12-14",{"date":37,"type":22},"2031-02-28",{"name":39,"class":40},"AstraZeneca","INDUSTRY",306,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":166},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol\n\n  * NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test =\\\u003C 7 days prior to pre-registration for persons of childbearing potential. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained =\\\u003C 28 days prior to pre-registration:\n\n  * Hemoglobin \\>= 9.0 g\u002FdL (Must be \\>= 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 or \\>= 1.5 X 10\\^9\u002FL\n  * Platelet count \\>= 100,000\u002Fmm\\^3 or \\>= 100 X 10\\^9\u002FL (Must be \\>=7 days after most recent transfusion)\n  * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3 x ULN or =\\\u003C 5 x ULN with liver metastases\n  * Creatinine =\\\u003C 1.5 x ULN OR calculated creatinine clearance must be \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease \\>= 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor \\>= 2 cm on pre-surgery evaluation imaging (residual disease \\>= 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing\n\n  * NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test ≤7 days prior to pre-registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive \\>= 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction =\\\u003C 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke =\\\u003C 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in =\\\u003C 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major Surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n  * Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002Fribonucleic acid (RNA)\u002Fdeoxyribonucleic acid (DNA) quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are \\>= 2 cores with passing cellularity; (3) \\>= 30% of tumor RNA with fragment sizes are \\>= 200 base pairs (DV200 \\>= 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Requirement for systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in","16 Years",{"count":52,"type":22},132,[54,55],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,28,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","2026-06-18",{"date":30,"type":33},{"date":160,"type":33},"2022-03-31",{"date":162,"type":22},"2028-03-31",{"name":164,"class":165},"Mayo Clinic","OTHER",1,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":214},"100452495","phase-1-testing-the-addition-of-ipatasertib-to-usual-chemotherapy-and-radiation-for-head-and-neck-cancer-100452495","NCT05172245","Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer","Phase 1\u002F1b Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary and other paranasal sinuses, and unknown primary of the head and neck), with measurable disease as per RECIST 1.1\n* Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in situ hybridization (ISH), or polymerase chain reaction (PCR). HPV testing is not required for other HNSCC primary tumor sites\n\n  * Patients with p16-positive tumors are eligible if clinical stage III (cT4 or cN3, M0) according to the American Joint Committee on Cancer (AJCC)\u002FTNM Staging System, 8th edition (Ed.)\n  * Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic) according to the AJCC\u002FTNM Staging System, 8th Ed.\n* Must be candidate for concurrent, definitive cisplatin and radiation therapy as judged by the treating physician\n* Able to swallow tablets at the time of enrollment\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of ipatasertib in combination with chemoradiation in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy of greater than 3 months\n* Absolute neutrophil count \\>= 3000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Platelets \\>= 150,000\u002FmcL\n* Serum albumin \\>= 3 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN \u002F 2 x institutional ULN\n* Alkaline phosphatase (ALP) =\\\u003C 2.0 x institutional ULN\n* Partial thromboplastin time (PTT) (or activated \\[a\\]PTT) and international normalized ratio (INR) =\\\u003C 1.5 institutional ULN (except for patients receiving anticoagulation therapy)\n* Creatinine clearance (CLcr) \\> 60 mL\u002Fmin\n\n  * For this calculation, use the Cockroft-Gault formula\n* Fasting glucose =\\\u003C 150 mg\u002FdL (8.3 mmol\u002FL) and (when indicated) glycosylated hemoglobin (HbA1c ) =\\\u003C 7.5% (58 mmol\u002Fmol)\n* Human immunodeficiency virus (HIV)-infected patients are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months\n* Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B virus surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV deoxyribonucleic acid \\[DNA\\] test) are eligible. Patients with chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy, if indicated. Patients undergoing current treatment with anti-viral therapy for HBV are ineligible\n* Patients with a history of hepatitis C virus (HCV) infection are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of ipatasertib on the developing human fetus are unknown. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 28 days after the last dose of ipatasertib and agreement to refrain from donating eggs during this same period. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib\n* Ability to understand and the willingness to sign a written informed consent document\n* For the expansion cohort only, patients must agree to undergo mandatory on-treatment biopsies, and have tumors amenable to on-treatment biopsies. This is not applicable to the dose escalation cohort where no on-treatment biopsies are obtained\n\nExclusion Criteria:\n\n* Primary tumor of nasopharynx, salivary, thyroid or parathyroid glands, or skin\n* Distant metastases from the current HNSCC\n* Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted. Biopsies, including those performed under anesthesia, are not considered surgery. Patients who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible\n* For patients with a prior history of another malignancy, no prior chemotherapy or radiation may have been administered within 6 weeks prior to study entry. Among patients who received prior radiation to the head and neck or adjacent anatomical site for another malignancy, there may be no overlap with current area to be irradiated\n* Current use of any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib or other agents used in study\n* Treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness, including active infection\n* Pregnant women are excluded from this study because ipatasertib is an oral AKT inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ipatasertib, breastfeeding should be discontinued if the mother is treated with ipatasertib. These potential risks may also apply to other agents used in this study\n* Patients with type I or type II diabetes mellitus requiring insulin at study entry. Patients with non-insulin dependent type II diabetes mellitus are eligible, as are patients who are on a stable dose of oral diabetes medication \\>= 4 weeks prior to initiation of study treatment. Patients with a history of diabetes mellitus, an abnormal fasting glucose level, or other signs or symptoms indicating diabetes mellitus, must meet the laboratory eligibility criteria for fasting blood glucose and hemoglobin A1c\n* History of or active inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)\n* History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills\n* Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)\n* Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen \\[HBsAg\\] or hepatitis C virus \\[HCV\\] antibody at screening), or cirrhosis\n* Grade \\>= 2 uncontrolled or untreated hypercholesterolemia (cholesterol \\> 300 mg\u002FdL or \\> 7.75 mmol\u002FL) or hypertriglyceridemia (triglycerides \\> 300 mg\u002FdL or \\> 3.42 mmol\u002FL)",{"count":175,"type":22},46,[54],"This phase I\u002FIb trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy (\"chemo-radiation\") in patients with head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin, which is a chemotherapy used in this trial, is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.",[179,180,28,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203],"Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Carcinoma of Unknown Primary","Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","Locally Advanced Laryngeal Squamous Cell Carcinoma","Locally Advanced Nasal Cavity Squamous Cell Carcinoma","Locally Advanced Oral Cavity Squamous Cell Carcinoma","Locally Advanced Oropharyngeal Squamous Cell Carcinoma","Locally Advanced Paranasal Sinus Squamous Cell Carcinoma","Locally Advanced Sinonasal Squamous Cell Carcinoma","Maxillary Sinus Squamous Cell Carcinoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Sinonasal Cancer AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Sinonasal Cancer AJCC v8","2026-05-15",{"date":206,"type":33},"2026-05-18",{"date":208,"type":33},"2022-09-19",{"date":210,"type":22},"2027-07-01",{"name":212,"class":213},"National Cancer Institute (NCI)","NIH",18,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":166},"100635598","phase-2-neoadjuvant-radio-immunotherapy-versus-immunotherapy-alone-for-locally-advanced-hnscc-100635598","NCT07554768","Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC","A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma","RAIN-HNSCC","Inclusion Criteria:\n\n1. Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC).\n2. Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer.\n3. PD-L1 expression with a Combined Positive Score (CPS) ≥ 1.\n4. Karnofsky Performance Status (KPS) score ≥ 70.\n5. Age between 18 and 70 years (inclusive).\n6. Evaluated by a multidisciplinary team (MDT) as resectable or borderline resectable, and suitable for preoperative Stereotactic Body Radiotherapy (SBRT).\n7. Adequate organ function within 7 days prior to enrollment, meeting laboratory criteria for hematology, liver, and renal function.\n8. Anatomical requirements for SBRT: Lesions must be localized with adequate anatomical space for high-precision radiotherapy without exceeding safety limits for Organs at Risk (OARs).\n9. Voluntary participation with a signed Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.\n2. Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections.\n3. Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU\u002FmL).\n4. Pregnant or breastfeeding women.\n5. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.","70 Years",{"count":225,"type":22},36,[55],"The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).",[229,28],"Head and Neck Squamous Cell Carcinoma",[231,232,233,234,235],"Neoadjuvant Therapy","Radio-immunotherapy","Adebrelimab","PD-L1 Inhibitor","SBRT","NOT_YET_RECRUITING","2026-04-23",{"date":239,"type":33},"2026-04-28",{"date":241,"type":22},"2026-05-01",{"date":243,"type":22},"2029-05-01",{"name":245,"class":165},"Chen Chunyan",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":166},"100633266","phase-3-becotatug-vedotin-mrg003-in-combination-with-pd-1-inhibitor-versus-pd-1-inhibitor-for-the-treatment-of-egfr-positive-cps1-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-100633266","NCT07524452","Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma","A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma： a Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS ≥ 1, with clinical stage (AJCC 8th edition): p16-positive oropharynx: Stage III (T4N0-2M0); p16-negative oropharynx: Stage III or IVA; larynx\u002Fhypopharynx\u002Foral cavity: Stage III or IVA;\n3. Eligible for curative-intent surgery as determined by the surgeon;\n4. Age: 18 to 75 years;\n5. ECOG performance status 0-1;\n6. Life expectancy greater than 6 months;\n7. At least one measurable lesion per RECIST 1.1;\n8. Adequate organ function, based on meeting all of the following criteria (no receipt of blood components or hematopoietic growth factors within 14 days prior to testing): hemoglobin ≥ 90 g\u002FL; absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; serum albumin ≥ 28 g\u002FL; total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL\u002Fmin; activated partial thromboplastin time and international normalized ratio (INR) ≤ 1.5 × ULN (patients receiving a stable dose of anticoagulant therapy, such as low molecular weight heparin or warfarin, may be enrolled if INR is within the expected therapeutic range for the anticoagulant). Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed, and patients with normal T3 and T4 levels may be enrolled;\n9. Baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO);\n10. Women of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptive pill, or condom) during the treatment period and for 3 months after the last dose;\n11. Good compliance.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. History of allergy to PD-1 inhibitors.\n3. History of other malignancies within the past 5 years or at enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors.\n4. Residual toxicity from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.) other than alopecia, fatigue, and grade 2 hypothyroidism, or clinically significant laboratory abnormalities greater than grade 1 (CTCAE v5.0).\n5. Uncontrolled cardiac conditions or diseases, such as: ① NYHA Class II or greater heart failure, ② unstable angina, ③ myocardial infarction within 1 year, and ④ patients with clinically significant ventricular arrhythmias requiring intervention.\n6. Grade ≥ 2 peripheral neuropathy (per CTCAE v5.0).\n7. Pulmonary embolism or deep vein thrombosis within 3 months prior to enrollment (excluding catheter-related thrombosis from infusion ports or PICC lines).\n8. Active bleeding, history of coagulation disorders, or patients receiving coumarin anticoagulant therapy.\n9. Known hypersensitivity to any component or excipient of vibecotamab (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known grade ≥ 3 hypersensitivity reaction to other prior anti-EGFR agents (including investigational drugs) or other monoclonal antibodies.\n10. Receipt of any of the following treatments:\n\n    ① Any investigational drug prior to the first dose of the current study drug.\n\n    ② Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period.\n\n    ③ Use of systemic corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for the use of corticosteroids for localized inflammation, prevention of allergies, or nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement doses greater than 10 mg prednisone equivalent per day are permitted.\n\n    ④ Administration of live vaccines within 4 weeks prior to the first dose of study drug.\n\n    ⑤ Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.\n11. Severe infection (greater than grade 2 per CTCAE), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications, occurring within 4 weeks prior to the first dose of study drug; baseline chest imaging indicating active pulmonary inflammation or signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or indicating the need for oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use).\n12. History of or concurrent severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n13. History of active autoimmune diseases or syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo that did not require any intervention in adulthood, or childhood asthma\u002Fallergy that has resolved, are not excluded.\n14. History of immunodeficiency, including HIV-positive status or other acquired\u002Fcongenital immunodeficiency diseases, or history of organ transplantation or bone marrow transplantation.\n15. Patients with active tuberculosis infection by history or CT findings, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without receiving formal treatment.\n16. Active hepatitis B (HBV DNA ≥ 2,000 IU\u002FmL or 10,000 copies\u002FmL) or hepatitis C (positive HCV antibody test with HCV RNA above the lower limit of detection).\n17. Uncontrolled pleural, peritoneal, pelvic, or pericardial effusion requiring drainage ≥ 1 time per month.\n18. Known history of substance abuse, alcoholism, or drug use.\n19. Inappropriate for inclusion based on the investigator's judgment.","75 Years",{"count":255,"type":22},430,[25],"This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .",[28],[260,261,262],"Resectabl locally advanced head and neck squamous cell carcinoma","Becotatug Vedotin","perioperative neoadjuvant and adjuvant therapy","2026-04-06",{"date":265,"type":33},"2026-04-13",{"date":267,"type":33},"2026-02-06",{"date":269,"type":22},"2032-02-28",{"name":271,"class":165},"Ming-Yuan Chen",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":166},"100589799","phase-2-clinical-trial-comparing-induction-treatment-with-egfr-adc-mrg003-alone-or-in-combination-with-the-anti-pd1-pucotenlimab-followed-by-radiochemotherapy-in-locally-advanced-squamous-cell-cancers-of-the-head-and-neck-100589799","NCT06959108","Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck","Randomized Phase 2 Trial of Induction Treatment of Anti-PD-1 Pucotenlimab and EGFR-ADC MRG003 Versus EGFR-ADC Alone Followed by Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN).","IDEAL","Inclusion Criteria:\n\n* Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Evaluable tumor burden assessed by H\\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1\n* Patients eligible to cisplatin-based chemotherapy\n* No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5\n* No prior treatment with chemotherapy, immunotherapy and targeted therapy for H\\&N cancer, radiotherapy or surgery in the head and neck region.\n\nExclusion Criteria:\n\n* Metastatic disease (stage IVC as per AJCC\u002FTNM, 8th Ed.).\n* Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).\n* Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment\n* History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ nonmuscular invasive bladder, cervix, uterine and\u002For prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum\u002Fanus.\n* Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction \\\u003C 50%.\n* Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis.",{"count":281,"type":22},106,[55],"The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy.\n\nPeople eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy).\n\nHalf of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant\\* after radiochemotherapy.",[28],"2026-04-01",{"date":287,"type":33},"2026-04-07",{"date":289,"type":33},"2025-10-13",{"date":291,"type":22},"2029-10",{"name":293,"class":165},"Groupe Oncologie Radiotherapie Tete et Cou",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":166},"100621485","phase-2-low-dose-radiotherapy-and-anti-pd-1-immunotherapy-as-neoadjuvant-treatment-for-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-100621485","NCT07371234","Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma","A Single Arm, Phase II Clinical Study of Low-Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Immunotherapy as Neoadjuvant Treatment for Surgically Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Voluntarily sign and date the informed consent form.\n* Untreated, histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) with CPS ≥1, classified as stage T3-4bN0M0 or T1-4bN1-3M0, corresponding to stage III-IVB according to the AJCC Staging System, 8th Edition.\n* Deemed eligible for curative surgery based on surgeon's assessment.\n* Age: 18 to 75 years.\n* ECOG performance status of 0 or 1.\n* Life expectancy greater than 6 months.\n* At least one measurable lesion as per RECIST 1.1 criteria.\n* Adequate organ function, defined as meeting all the following criteria (without receipt of blood products, colony-stimulating factors, or hematopoietic growth factors within 14 days prior to testing): Hemoglobin ≥ 90 g\u002FL Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Serum albumin ≥ 28 g\u002FL Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin Activated partial thromboplastin time (aPTT) and international normalized ratio (INR) ≤ 1.5 × ULN (patients on a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin are eligible if INR is within the therapeutic range) Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels must be evaluated, and patients with normal T3 and T4 levels are eligible.\n* Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the treatment period and for 3 months after the last dose.\n* Good compliance with the study protocol.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* History of allergy to PD-1 inhibitors.\n* History of other malignancies within the past 5 years or at the time of enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n* Uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure of NYHA Class II or higher, (2) unstable angina, (3) myocardial infarction within the past year, and (4) patients with clinically significant ventricular or supraventricular arrhythmias requiring intervention.\n* Any of the following prior treatments: ① Receipt of any investigational drug prior to the first dose of the current study drug. ② Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or an interventional study during the follow-up phase. ③ Systemic treatment with corticosteroids (\\>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the study drug, with the exception of topical corticosteroid use for local inflammation, prevention of allergic reactions, or management of nausea and vomiting. Inhaled or topical steroids and physiologic replacement doses of corticosteroids (≤10 mg prednisone equivalent daily) are permitted in the absence of active autoimmune disease. ④ Administration of live vaccines within 4 weeks prior to the first dose of the study drug. ⑤ Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.\n* Severe infection (Grade \\>2 according to Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, or complicating infections requiring hospitalization, occurring within 4 weeks prior to the first dose of the study drug; or active pulmonary inflammation or signs\u002Fsymptoms of infection indicated by baseline chest imaging within 2 weeks prior to the first dose, or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotics).\n* History of active autoimmune diseases and syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo not requiring intervention in adulthood, or childhood asthma\u002Fallergies that have resolved, are not excluded.\n* History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ or bone marrow transplantation.\n* Patients with active tuberculosis infection based on medical history or CT findings, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without adequate course of anti-tuberculosis therapy.\n* Active hepatitis B (HBV DNA ≥ 2,000 IU\u002FmL or 10,000 copies\u002FmL) or hepatitis C (positive HCV antibody test with HCV RNA above the lower limit of detection).\n* Known history of substance abuse, alcohol abuse, or drug use.\n* Considered ineligible for participation based on the investigator's judgment.",{"count":302,"type":22},22,[55],"Over 60% of head and neck squamous cell carcinoma (HNSCC) patients are diagnosed at a locally advanced stage. While standard treatments involve surgery and chemoradiotherapy, prognosis remains poor, with 50-60% experiencing local recurrence within two years. Neoadjuvant therapy can potentially reduce tumor burden, preserve organs, and lower distant metastasis risk. Despite the KEYNOTE-689 trial showing that adjuvant two-cycle pembrolizumab increased major pathological response to 9.8% in stage III-IVB HNSCC, this result remains insufficient. More effective immunotherapy-based combinations are urgently needed to improve long-term survival after neoadjuvant treatment.\n\nPreclinical and clinical evidence indicates that low-dose radiotherapy can activate the tumor immune microenvironment and synergize with immunotherapy. Based on this rationale, the present clinical trial will evaluate a neoadjuvant regimen combining LDRT with two cycles of an anti-PD-1 inhibitor in patients with surgically resectable, locally advanced HNSCC.",[28],[307,308,28],"low-dose radiotherapy","neoadjuvant immunotherapy","2026-01-31",{"date":311,"type":33},"2026-02-03",{"date":313,"type":33},"2025-12-15",{"date":315,"type":22},"2028-12-30",{"name":317,"class":165},"Xiwei XU",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":166},"100621381","comparison-of-efficacy-between-de-escalated-surgery-and-standard-surgery-after-neoadjuvant-immunotherapy-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100621381","NCT07369882","Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Randomized, Single-center Exploratory Clinical Study","Inclusion Criteria:\n\n* Patients diagnosed with stage III-IVa head and neck squamous cell carcinoma (HNSCC) according to the AJCC 8th edition TNM staging system, who have achieved a partial response (PR) or complete response (CR) after receiving neoadjuvant immunochemotherapy consisting of a PD-1 inhibitor in combination with nab-paclitaxel and carboplatin\u002Fcisplatin.\n* No prior history of other malignant tumors.\n* Aged between 18 and 75 years.\n* Normal baseline (preoperative) clinical and laboratory findings:\n* 1.Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without the use of granulocyte colony-stimulating factor (G-CSF) within the previous 14 days\n* 2.Platelet count ≥ 100 × 10⁹\u002FL without blood transfusion within the previous 14 days\n* 3.Hemoglobin \\> 9 g\u002FdL without blood transfusion or erythropoietin use within the previous 14 days\n* 4.Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n* 5\\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* 6\\. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin\n* 7\\. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN\n* 8\\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with TSH outside the normal range may be included if total T3 (or FT3) and FT4 are within normal limits\n* 9\\. Normal myocardial enzyme profile (minor laboratory abnormalities judged by the investigator to be clinically insignificant are acceptable)\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1). If the urine test is indeterminate, a serum test must be performed. Non-childbearing females are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy.\n* All subjects (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate \\\u003C1%) during treatment and for at least 120 days after the last dose of study drug, or 180 days after the last dose of chemotherapy.\n* Adverse events related to neoadjuvant therapy (e.g., bone marrow suppression, thyroiditis, hypothyroidism, hepatitis, nephritis, myocarditis, myositis, etc.) must have been adequately controlled and resolved to grade 0-2 before surgery. Patients assessed by anesthesiology as fit for general anesthesia may be included.\n* Patients with pre-existing comorbidities prior to neoadjuvant therapy may also be enrolled if evaluated by anesthesiology and deemed able to tolerate general anesthesia.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of another malignant tumor, or the primary lesion at the time of neoadjuvant therapy was not oral cancer.\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to treatment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n* History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1\u002F2 antibody).\n* Untreated active hepatitis B infection, defined as HBsAg positivity with HBV-DNA levels exceeding the upper limit of normal (ULN) at the study site laboratory. Subjects meeting the following criteria may be enrolled:\n* a. HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) prior to first dosing, provided antiviral therapy is administered throughout the study period to prevent viral reactivation\n* b. Subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV-DNA(-) do not require prophylactic antiviral therapy but must undergo close monitoring for viral reactivation.\n* Active hepatitis C virus (HCV) infection, defined as positive HCV antibody with detectable HCV-RNA above the lower limit of detection.\n* Pregnant or lactating women.\n* Presence of severe or uncontrolled systemic diseases, including but not limited to:\n* 1\\. Cardiac disorders: severe arrhythmias (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or persistent atrial fibrillation), unstable angina, or congestive heart failure (NYHA class ≥ II)\n* 2\\. Vascular diseases: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months prior to enrollment\n* 3\\. Poorly controlled hypertension: systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg\n* 4\\. Pulmonary diseases: noninfectious pneumonitis requiring corticosteroid treatment within 1 year before first dosing, or active interstitial lung disease\n* 5\\. Infectious diseases: active infections requiring systemic therapy, or severe uncontrolled infections\n* 6\\. Active pulmonary tuberculosis\n* 7\\. Gastrointestinal diseases: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction\n* 8\\. Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis\n* 9\\. Uncontrolled diabetes mellitus: fasting blood glucose (FBG) \\> 10 mmol\u002FL\n* 10\\. Renal dysfunction: urine protein ≥ ++ on routine urinalysis and 24-hour urinary protein \\> 1.0 g\n* 11\\. Psychiatric disorders: severe mental illness that may affect treatment compliance.",{"count":326,"type":22},60,[328],"NA","This is a single-center, open-label, randomized, controlled, exploratory clinical trial designed to evaluate the efficacy and safety of de-escalated surgery compared with standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who achieved a partial response (PR) or complete response (CR) after neoadjuvant immunochemotherapy. Eligible patients will be randomly assigned in a 1:1 ratio to either the de-escalated surgery group (experimental) or the standard surgery group (control). The de-escalated surgery group will undergo limited tumor resection and selective neck dissection based on clinical and imaging response, while preserving important anatomical structures and functions when feasible. The control group will receive standard surgical treatment following NCCN guidelines. All patients will be evaluated using RECIST 1.1 criteria for radiological response and will undergo enhanced CT or MRI at baseline, before the second cycle of neoadjuvant therapy, within one week before surgery, 30 days after surgery, and every 3 months thereafter until 2 years post-surgery, disease recurrence, death, or study completion. The study aims to assess whether de-escalated surgery can achieve similar oncologic outcomes while improving postoperative function and quality of life. The primary endpoints are disease-free survival (DFS), health-related quality of life (HRQoL), and 3- and 5-year overall survival rates (OS rate). A total of 60 patients will be enrolled over a 3-year period, with 30 in each group.",[28],[332,333,334,335],"head and neck squamous cell carcinoma","locally advanced","De-escalated Surgery","Neoadjuvant","2026-01-18",{"date":338,"type":33},"2026-01-27",{"date":340,"type":22},"2026-01-12",{"date":342,"type":22},"2030-01-31",{"name":344,"class":165},"Qunxing Li,MD",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":166},"100605919","early-phase-1-18f-arag-pet-imaging-in-la-hnscc-100605919","NCT07168785","[18F]-AraG PET Imaging in LA HNSCC","[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\n1. Patients ≥18 years of age.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. LA-HNSCC in the larynx, hypopharynx, or human papillomavirus (HPV) negative oropharynx and is planning to receive definitive CRT as the SOC treatment, which includes a total of 70 Gy of radiation dose in 33 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP).\n4. Tumor stage III and IV (AJCC 8th edition).\n5. Unresectable cases.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n7. Willing and able to maintain the imaging protocol.\n8. Patients planning to receive pre-CRT and post-CRT FDG PET\u002FCT scans as part of the standard clinical practice.\n\nExclusion Criteria\n\n1. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET\u002FCT scan.\n2. Pregnant or breastfeeding.\n3. Patients that will receive definitive induction chemotherapy or surgery.\n4. Patients who are unable to complete the radiation therapy.",{"count":353,"type":22},5,[355],"EARLY_PHASE1","This study will use \\[18F\\]-AraG PET\u002FCT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell carcinoma (LA-HNSCC), and are planning to undergo standard of care chemoradiotherapy for treatment.",[358,28],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[360,361,362],"AraG PET\u002FCT","Chemoradiotherapy","[18F]-AraG PET\u002FCT","2025-09-04",{"date":365,"type":33},"2025-09-11",{"date":367,"type":22},"2025-10-01",{"date":369,"type":22},"2027-10",{"name":371,"class":165},"Indiana University",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100335563","low-dose-weekly-vs-high-dose-cisplatin-100335563","NCT03649048","Low-Dose Weekly vs High-Dose Cisplatin","Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer.","RADIO","Inclusion Criteria:\n\n* Age 18 or older\n* Willing and able to provide written informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Histologically or cytologically confirmed squamous cell carcinoma\n* Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown\n* Patients must be deemed suitable for HD cisplatin therapy based on tumor characteristics, clinical condition and comorbidities in the judgement of the treating medical oncologist.\n* Patients must be planned to receive radical intent radiation treatment based on clinical condition, comorbidities and tumor characteristics in the judgment of the treating radiation oncologist\n* Adequate organ and marrow function independent of transfusion for at least 7 days prior to randomization defined as:\n\n  * Hemoglobin \\> 80 g\u002FL; Absolute neutrophil count \\>1.5x10⁹ \u002FL, platelets \\>100x10⁹\u002FL; Bilirubin \\\u003C 35 umol\u002FL; AST or ALT \\\u003C 3 x the upper limit of normal; Calculated creatinine clearance (as determined by Cockcroft- Gault) \\> 50 ml\u002Fmin\n\nMales:\n\nCreatinine Clearance = Weight (kg) x (140 - Age) (mL\u002Fmin) 72 x serum creatinine (mg\u002FdL)\n\nFemales:\n\nCreatinine Clearance = Weight (kg) x (140 - Age) x 0.85 (mL\u002Fmin) 72 x serum creatinine (mg\u002FdL)\n\n* Patient must be assessed at head and neck cancer multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization.\n\nExclusion Criteria:\n\n* Serious medical comorbidities or other contraindications to radiotherapy and\u002For chemotherapy.\n* Prior history of head and neck cancer within 5 years.\n* Nasopharyngeal primary confirmed or suspected.\n* Severe hearing loss as determined clinically Pre-existing use of hearing aids.\n* Peripheral neuropathy .grade 2 (CTCAE v4.02).\n* Prior or planned neoadjuvant chemotherapy prior to CRT.\n* Prior head and neck radiation at any time.\n* Distant metastatic disease.\n* Inability to attend full course of radiotherapy or follow-up visits.\n* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer or in-situ carcinoma.\n* Unable or unwilling to complete QOL questionnaires.\n* Pregnant or lactating women.\n* Unable to use dual method of contraception.",{"count":381,"type":22},100,[328],"This study is a prospective open-label randomized clinical trial. Following informed consent eligible LASCCHN patients (n=100) planned for CRT will be stratified by tumor p16 status and then randomized in a 1:1 fashion to either concurrent HD cisplatin or concurrent weekly LD cisplatin.",[28],"2025-07-28",{"date":387,"type":33},"2025-07-31",{"date":389,"type":33},"2018-11-05",{"date":391,"type":22},"2028-09",{"name":393,"class":165},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",3,{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":166},"100552217","phase-2-tirilizumab-with-albumin-bound-paclitaxel-and-cisplatin-for-locally-advanced-resectable-oral-squamous-cell-carcinoma-100552217","NCT06470217","Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma","A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma","OPTimal","Inclusion Criteria:\n\nAge 18-75 years, male or female; Patients with primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity with measurable lesions (≥10 mm on spiral CT scan, fulfilling RECIST 1.1 criteria) as confirmed by pathohistology; ECOG score of 0 or 1; Expected survival ≥ 12 weeks; Tumour tissue (paraffin specimen or fresh tumour tissue less than 2 years old) for PD-L1 detection is available; Organ function levels must meet the following requirements (14 days prior to first dose of study drug) Bone Marrow:Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL, Platelet (PLT) ≥ 100 x 109\u002FL, Haemoglobin (HB) ≥ 9g\u002FdL (no blood transfusion or receipt of component blood within 14 days prior to the test); Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is hepatic metastasis, AST and ALT are allowed to be ≤ 5 times the upper limit of normal); and Kidney: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥60ml\u002Fmin, urea nitrogen ≤200mg\u002FL; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be enrolled) Urine protein ≤1+, if urine protein \\>1+, 24-hour urine protein measurement should be collected, and its total amount should be ≤1g; and Normal cardiac function, i.e. normal ECG or abnormalities without clinical significance and left ventricular ejection fraction (LVEF) \\>50% on cardiac ultrasound.\n\nReproductively active female subjects must have a negative serum pregnancy test prior to the first dose of the test drug.\n\nReproductively active male or female subjects must be using a highly effective method of contraception (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier method of contraception combined with spermicide) throughout the course of the trial and continue to use contraception for 90 days after completion of treatment; Subjects volunteered to join the study, signed an informed consent form, were compliant and co-operated with follow-up visits.\n\nExclusion Criteria:\n\nWith distant metastatic lesions or localised lesions without indication for surgery (stage IVb or IVc patients); Prior history of a primary tumour of nasopharyngeal carcinoma; Patients who have participated or are participating in a clinical trial of another drug\u002Ftherapy within 4 weeks prior to the first dose of study drug; Major surgical procedure performed\u002Freceived within 4 weeks prior to the first dose of study drug or have not recovered from the side effects of this procedure, live vaccination, immunotherapy, radiotherapy within 2 weeks; Concurrently receiving any other anti-tumour therapy; Patient has any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism; vitiligo that does not require systemic therapy may be included; asthma that has been in complete remission in childhood and does not require any intervention in adulthood may be be included; asthma in which the patient requires medical intervention with bronchodilators cannot be included); Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose \\>10mg\u002Fday prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrolment; History of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, and carcinoma in situ of the cervix; Patients who have received haematopoietic stimulating factors, such as those receiving granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first dose of study drug; Prior treatment with PD-1\u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibodies or activating or inhibitory drugs targeting T-cell receptors (e.g., OX40, CD137); Positive HIV antibody or syphilis spirochete antibody test results; Patients with active Hepatitis B or Hepatitis C:. If HBsAg or HBcAb is positive, HBV DNA (results above the upper limit of the normal range).\n\nIf HCV antibody test result is positive, add HCV RNA (result above upper limit of normal range); Known hypersensitivity to recombinant humanised PD-1 monoclonal antibody drugs and their components; and Active lung disease (interstitial pneumonitis, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis; Have any uncontrolled clinical problems, including but not limited to. Persistent or active (serious) infections. Medication-uncontrolled hypertension (blood pressure persistently greater than 150\u002F90 mmHg); Poorly controlled diabetes mellitus. Heart disease (class III\u002FIV congestive heart failure or heart block as defined by the New York Heart Association).\n\nThe following within 6 months prior to first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accidents, transient ischaemic attacks, cerebral embolism; Previous stem cell transplant or organ transplant; Persons with a history of psychotropic substance abuse that they are unable to abstain from or persons with a history of psychotic disorders; Other severe, acute, or chronic medical conditions or abnormal laboratory tests that, in the investigator's judgement, may increase the risks associated with participation in the study or may interfere with the interpretation of study results; Patients who, in the judgement of the investigator, have poor compliance, or other conditions that make participation in this trial unsuitable.",{"count":404,"type":22},116,[55],"The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.\n\nControl regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.",[28],"2025-02-09",{"date":410,"type":33},"2025-02-11",{"date":412,"type":33},"2024-06-19",{"date":414,"type":22},"2027-06-19",{"name":416,"class":165},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":166},"100560082","phase-1-de-escalation-radiation-strategy-after-nac-in-combination-with-ici-in-lahnscc-100560082","NCT06572514","De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC","The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC","Inclusion Criteria:\n\n1. ≥18 years old, with medical decision-making capacity\n2. Signed informed consent\n3. ECOG score of 0-1\n4. Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer\n5. Exclusion of distant metastasis\n6. Clearly evaluable lesion (per RECIST 1.1 criteria)\n7. Expected life span ≥6 months\n8. Laboratory test results meet the following requirements: WBC ≥ 3×10\\^9\u002FL, ANC ≥ 2.0×10\\^9\u002FL, PLT ≥ 80×10\\^9\u002FL, Hb ≥ 80g\u002FL (according to the normal standards of the central laboratory); Liver function: Total bilirubin, ALT, and AST all ≤ 1.5x UNL (upper normal limit); AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x IULN (upper normal limit); Kidney function: Cr ≤ 1.5x UNL (upper normal limit), and creatinine clearance rate ≥ 60 ml\u002Fmin (calculated using the Cockcroft and Gault formula); Thyroid function T3 and T4 within the normal range (hypothyroidism can be corrected with oral thyroid hormone supplementation); Heart function: All three cardiac enzymes and pro-BNP within the normal range, no history of heart attack; Adrenal function: Normal cortisol secretion function or correctable based on endocrine assessment\n9. HBV-infected patients with HBV-DNA copy numbers less than 500 IU\u002Fml\n10. No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).\n\nExclusion Criteria:\n\n1. No indications for curative radiotherapy or contraindications to radiochemotherapy.\n2. Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).\n3. Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.\n4. Previous history of autoimmune diseases or in the active phase of the disease \\[including but not limited to inflammatory bowel disease (IBD), rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barré syndrome)\\], vitiligo, and correctable endocrine deficiencies such as hypothyroidism and physiological cortisol deficiency can be included in the study and are not exclusion criteria.\n5. History of active tuberculosis or non-infectious pneumonia or any clinical evidence.\n6. Active phase of viral hepatitis, HBV DNA \\> 500 IU\u002Fml.\n7. Acquired Immunodeficiency Syndrome (AIDS).\n8. Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.\n9. Prior immunotherapy for other tumors.\n10. History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).\n11. Pregnant or lactating women.\n12. Concurrently suffering from other malignant tumors.\n13. Cannot or unwilling to sign the informed consent form.\n14. Vaccination within 4 weeks.\n15. Allergic reaction to the investigational drug.",{"count":425,"type":22},20,[54,55],"This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.",[28],"2024-08-26",{"date":431,"type":33},"2024-08-27",{"date":433,"type":33},"2023-10-17",{"date":435,"type":22},"2027-04",{"name":437,"class":165},"Ruijin Hospital",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":4},"100498655","phase-2-toripalimab-maintenance-for-locally-advanced-head-and-neck-squamous-cell-carcinoma-100498655","NCT05773079","Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma","Toripalimab Maintenance After First-line Comprehensive Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Single-arm, Phase II Study","Inclusion Criteria:\n\n* Locally advanced squamous cell carcinoma of the head and neck (AJCC8thIII-IV) confirmed by pathology in the initial treatment;\n* No residual lesions after first-line surgery\u002Fradiotherapy\u002Fchemotherapy\u002Ftargeted comprehensive treatment;\n* Associated high risk factors: T3-4, regional lymph node positive, vascular invasion, neural invasion, lymph node capsular invasion, incisional margin positive;\n* The patients' age is between 18 and 70 years old;\n* The ECOG physical fitness status score is 0 or 1;\n* Estimated survival period ≥ 3 months;\n* The main organ functions meet the following standards: (1) Blood routine (without blood transfusion within 14 days): HGB ≥ 110g \u002FL, WBC ≥ 3.0 × 10\\^9\\\\\u002FL， NEUT≥1.5 × 10\\^9\\\\\u002FL，PLT ≥75 × 10\\^9\\\\\u002FL； (2) Biochemical: BIL ≤ 1.5 times the upper limit of normal value (ULN), ALT and AST ≤ 2.0 × ULN, serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50ml \u002Fmin; (3) Occult blood in stool (-); (4) Normal urine routine, or urine protein\\<(++), or 24-hour urine protein\\<1.0g; (5) Left ventricular ejection fraction (LVEF) ≥ 50%. (6) The blood coagulation function is normal, and there is no active bleeding or thrombosis disease. A. International standardized ratio INR ≤ 1.5 × ULN； B. Partial thromboplastin time APTT ≤ 1.5 × ULN； C. Prothrombin time PT ≤ 1.5ULN. (7) Thyroid stimulating hormone (TSH) ≤ 1.5ULN; If the T3 and T4 levels are abnormal, they should be investigated. If the T3 and T4 levels are normal, they can be selected;\n* Women of childbearing age should agree to use contraceptives (such as intrauterine devices, birth control pills, or condoms) during and within 3 months after the end of medication; \"Within 7 days prior to study enrollment, the serum or urine pregnancy test was negative and must be a non lactating patient. The male should agree to use contraception during the study period and within 3 months after the end of the study period;\n* Patients with hepatitis B virus (HBV) infection, inactive\u002Fasymptomatic HBV carriers, or patients with chronic or active HBV who received antiviral therapy for\\>1 week at the time of screening are allowed to be enrolled and continue treatment for more than 6 months after the study drug treatment. Patients with positive hepatitis C antibodies who have started anti hepatitis C virus treatment at the time of screening will be allowed to participate in the group;\n* Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* Distant metastasis of the tumor was detected upon enrollment;\n* Have a history of allergy to PD-1 monoclonal antibody or drug components;\n* There has been a history of other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma;\n* Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n* Have received any of the following treatments: a. Have previously received treatment with immunosuppressive drugs; B. Have received any investigational drug within 4 weeks before the first use of the investigational drug; C. Joining another clinical study at the same time, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up; D. Subjects who require systemic treatment with corticosteroids (greater than 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first use of the study drug, excluding the use of corticosteroids for local inflammation and the prevention of allergies, nausea, and vomiting. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortical hormone replacement with a dose greater than 10 mg\u002Fday of prednisone; E. Have received an anti-tumor vaccine or a live vaccine within 4 weeks before the first administration of the study drug; F. Major surgery or severe trauma requiring removal of the disease within 4 weeks before the first use of the study drug;\n* Serious infections (CTCAE greater than Level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, intracranial infection, etc. that require hospitalization;\n* Have a history of active autoimmune diseases and autoimmune diseases, but does not include autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin; Patients with vitiligo or recovered childhood asthma\u002Fallergies who do not require any intervention in adulthood;\n* Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation;\n* Have a history of interstitial lung disease and non infectious pneumonia;\n* Patients who have a history of active pulmonary tuberculosis infection through medical history or CT examination, or who have a history of active pulmonary tuberculosis infection within 1 year before enrollment, or who have a history of active pulmonary tuberculosis infection before 1 year but have not received formal treatment;\n* Subjects with active hepatitis (HBV DNA ≥ 2000 IU \u002Fml or 10000 copies \u002Fml) who have not been treated, and hepatitis C (hepatitis C antibody positive, and HCV-RNA above the detection limit of the analytical method) who have not been treated;\n* Known history of abuse, alcoholism, and drug abuse of psychotropic substances;\n* KPS score\\\u003C60, intolerance to anti-tumor therapy;\n* Pregnant or lactating women;\n* Engaging or expected to participate in other clinical studies;\n* Researchers believe that it is not suitable for inclusion.",{"count":446,"type":22},28,[55],"The guidelines for locally advanced head and neck squamous cell carcinoma currently recommend surgery \u002F radiotherapy \u002F chemotherapy \u002F targeted therapy. However, the median PFS of patients with high risk factors after comprehensive treatment was about 17 months, and the 2-year PFS rate was about 40 %. The KEYNOTE-048 study showed that PD-1 monoclonal antibody alone or in combination with chemotherapy significantly improved survival and was safe for recurrent \u002F metastatic head and neck squamous cell carcinoma. Therefore, PD-1 monoclonal antibody has become the first-line treatment of metastatic head and neck squamous cell carcinoma. For locally advanced head and neck squamous cell carcinoma, the existing studies on immunotherapy for neoadjuvant or concurrent chemoradiotherapy have not been clearly concluded. We previously used PD-1 monoclonal antibody for the maintenance treatment of patients after the first-line treatment of locally advanced head and neck squamous cell carcinoma, without residual tumor, which showed a trend of prolonged survival. Therefore, this study intends to explore whether the maintenance treatment of PD-1 monoclonal antibody terripril can further improve the survival of patients with locally advanced head and neck squamous cell carcinoma with high risk factors and no residual tumor after first-line comprehensive treatment, and the safety is good.",[28],[451,452,453,454],"Squamous Cell Carcinoma of Head and Neck","Toripalimab","PFS","Immunotherapy","2024-03-28",{"date":457,"type":33},"2024-04-01",{"date":459,"type":22},"2024-05",{"date":461,"type":22},"2028-06",{"name":463,"class":165},"Nanfang Hospital, Southern Medical University",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":166},"100534581","phase-2-a-prospective-randomized-controlled-study-of-immune-checkpoint-maintenance-therapy-after-radiotherapy-and-chemotherapy-for-locally-advanced-head-and-neck-tumors-based-on-peripheral-blood-cd8tex-detection-in-peripheral-blood-100534581","NCT06240689","A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood","A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years old, ≤ 75 years old.\n2. Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.\n3. Patients undergoing concurrent chemoradiotherapy\n4. ECOG performance status of 0 to 1.\n5. Life expectancy of at least 12 weeks.\n6. At least one measurable lesion\n7. Blood test: absolute neutrophil count (ANC) \\> 1.5×109\u002FL, hemoglobin \\> 8g\u002FdL and platelet \\> 100 ×109\u002FL (subject to the normal value of the clinical trial center).\n8. Prothrombin time (PT) \\\u003C1.5 times the upper limit of normal and normal thromboplastin time (APTT) \\\u003C1.5 times the upper limit of normal.\n9. Laboratory examination, serum creatinine less than or equal to 1.5 times the upper limit of the reference range of normal values (If serum creatinine is elevated, 24-hour urine must be collected. Except for the 24-hour creatinine clearance rate is \\> 50ml\u002Fmin).\n10. In the absence of liver metastases, ALT or AST is less than or equal to 2.5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 1.5 times the upper limit of the reference range of normal values; for patients with liver metastases, ALT or AST is less than or equal to 5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 3 times of the upper limit of the reference range of normal values.\n11. Females of childbearing potential must be willing to use adequate contraception for the duration of study drug treatment.\n12. Signed informed consent.\n13. At the end of radiotherapy, the proportion of PD1+CD8T cells in peripheral blood is greater than 10%, or more than 2 times higher than baseline\n\nExclusion Criteria:\n\n1. Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.\n2. Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use of physiologic doses of corticosteroids may be approved.\n3. Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative therapy are excluded.\n4. Have an active infection requiring systemic therapy.\n5. Medical history or evidence of disease that may confound the results of the trial, prevent the subject from participating in the study throughout the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the best interest of the subject.\n6. Known psychiatric or substance abuse disorder that may affect compliance with test requirements.\n7. Female subjects who are pregnant or lactating, or who are expected to conceive during the planned trial period or up to 180 days after the last dose of study treatment, or male subjects whose spouse is preparing to become pregnant.\n8. Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) infection.",{"count":472,"type":22},104,[55],"The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are:\n\nHow works well the Sintilimab was in the treatment group？ How safe the Sintilimab is？ Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence.\n\nResearchers will compare invention group to control group to see if the Sintilimab works well.",[28],"2024-02-02",{"date":478,"type":33},"2024-02-05",{"date":480,"type":33},"2024-01-25",{"date":482,"type":22},"2027-01-05",{"name":484,"class":165},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":495,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":166},"100506322","tpextreme-induced-chemotherapy-followed-by-surgery-and-radiotherapy-in-the-oral-carcinoma-100506322","NCT05872880","TPExtreme Induced Chemotherapy Followed by Surgery and Radiotherapy in the Oral Carcinoma.","A Multicenter Prospective Real-world Study of TPExtreme Induced Chemotherapy Followed by Radical Surgery\u002FModified Radical Surgery and Radiotherapy in the Treatment of Locally Advanced Oral Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. ECOG(Eastern Cooperative Oncology Group) score: 0\\~1.\n2. New patients, confirmed by pathological biopsy for squamous cell carcinoma of the oral mucosa.\n3. Tumor site: the tongue body, mouth floor, gums, buccal mucosa, after the hard palate, molar area.\n4. TNM(Primary Tumor, Regional Node, Metastasis) staging (stage Ⅲ - Ⅳ B): T2-4bN0-3bM0.\n5. After the assessment of tumor can be excised completely, or after the induction therapy may be removed completely.\n6. can tolerate set by general treatment, no surgical contraindications, through the basin of chest CT + body Bone radionuclide scanning or PET-CT(Positron Emission Tomography \u002F Computed Tomography) to rule out distant metastasis.\n7. Pregnancy tests were performed in women of childbearing age (15-49 years old) within 7 days before treatment and the results were negative; Fertile male and female patients must consent to the use of effective contraceptive measures to ensure that during the trial and three months after withdrawal of pregnancy.\n8. voluntarily signed informed consent and are willing and able to comply with the requirements of the study schedule follow-up, treatment, Laboratory testing and other research requirements.\n\nExclusion Criteria:\n\n1. Have previously received relevant antitumor therapy, including chemotherapy, radiotherapy and immunotherapy.\n2. Refused to sign the informed consent.\n3. Patients who refuse to accept treatment options in clinical studies: patients who cannot get treatment to proceed smoothly; Patients unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.\n4. Known to be allergic to the drugs that may be used to treat it.\n5. For patients with poor general condition who cannot tolerate treatment. (Routine examination, such as three routine examinations, blood biochemical examination, electrocardiogram, chest radiograph, etc, to judge the general condition, when the results prompt HB(hemoglobin)\\\u003C60g\u002FL, WBC(white blood count)\\\u003C3.0×10\\^9\u002FL, PLT(platelet count)\\\u003C80×10\\^9\u002FL, Serum creatinine\\>133umol\u002FL, it was considered that the general condition was poor and the treatment could not proceed smoothly, so conservative treatment was recommended)\n6. Staging did not meet the inclusion criteria: patients with early clinical T1-2N0 oral cancer or patients with distant metastatic M1.\n7. Assess patients who cannot be surgically resected, such as primary lesions or cervical metastases that invade vital structures such as the craniocerebral vital centers and carotid arteries.\n8. Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age).\n9. Patients with past or current malignancies other than adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma.\n10. Participated in other clinical studies within the past 30 days.\n11. Other conditions assessed by the researchers that could compromise patient safety or poor compliance, such as having a serious illness (including mental illness), severely abnormal test results, and other family or social high-risk risk factors.","65 Years",{"count":494,"type":22},124,"OBSERVATIONAL","Research shows that most oral cancer patients are already locally advanced when first diagnosed. Even after surgery and radiation, nearly half of patients develop recurrence or metastasis. Even in patients who survive, there is a serious decline in quality of life due to the after-effects of surgery and radiation. Many patients therefore refuse surgery and lose the treatment opportunity. Many studies at home and abroad have found that preoperative induction chemotherapy for locally advanced tumors can reduce tumor load, reduce tumor scope, eliminate distant micro metastases, reduce the risk of recurrence and metastasis, and improve organ preservation rate. It has been confirmed in many clinical studies and our clinical practice of oral cancer MDT(Multi-Disciplinary Treatment) that induction chemotherapy with TPExtreme protocol (cetuximab + albumin-paclitaxel + cisplatin) for patients with locally advanced oral cancer can significantly reduce the tumor with a good objective response, which can create good conditions for surgery. Therefore, for patients sensitive to induction chemotherapy, there are no authoritative guidelines and clinical studies to say what is the scope of surgery. One option is for the thoroughness of the tumor resection, which is still the same as the scope of the tumor before induction therapy, but the scope of the surgery is still large, and the damage to the patient's quality of life is also serious. The other option is to perform modified radical surgery according to the scope of residual tumor lesions after induction therapy, with less trauma and less damage to the quality of life. Postoperative radiotherapy (chemical) therapy is to reduce the risk of recurrence. Our preliminary clinical practice also shows that Patients sensitive to induction chemotherapy can obtain better survival rate and quality of life after comprehensive treatment including modified radical surgery. This treatment mode is feasible, but the overall efficacy evaluation needs further study. Therefore, in this real world prospective clinical study, patients with oral cancer sensitive to induction chemotherapy will be treated with modified radical surgery or traditional radical surgery in full compliance with the patient's wishes. Through clinical observation and follow-up statistics. To explore the effects of two treatment regimens on survival rate and quality of life in order to find the best treatment mode.",[498,28],"Oral Squamous Cell Carcinoma","2023-05-14",{"date":501,"type":33},"2023-05-24",{"date":503,"type":33},"2022-04-01",{"date":505,"type":22},"2026-09",{"name":507,"class":165},"Xiangya Hospital of Central South University"]