[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-squamous-cell-carcinoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,61,74,104,135,160,189,214,245,271,305,326,356,382,407,434,464,489,518,541,563,582,601,621],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[28,29,30,31,32,33,34,35,36,37,38,39],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[41,42,43,44,45,46,47],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":21},"2026-07-16",{"date":56,"type":21},"2037-10-01",{"name":58,"class":59},"National Cancer Institute (NCI)","NIH",1,{"id":62,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":26,"conditions":65,"keywords":66,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":60},"100643883",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39],[41,42,43,44,45,46,47],"2026-07-01",{"date":69,"type":52},"2026-07-02",{"date":71,"type":21},"2026-07-07",{"date":56,"type":21},{"name":58,"class":59},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":60},"100520384","people-living-with-hiv-oral-and-oropharyngeal-cancer-and-health-equity-100520384","NCT06055868","People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity","People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study","Inclusion Criteria:\n\n* Participants must be 18-years old or older.\n* Participants must be individuals living with HIV\n* Ability to speak and understand English\n* Identify as one or more racial\u002Fethnic minority groups or sexual and gender minority groups\n* All genders and members of all races and ethnic groups are eligible for this study.\n\nExclusion Criteria:\n\n* Younger than 18-years old.\n* Not living with HIV.\n* Not able to speak and understand English.\n* Not classified as one or more racial\u002Fethnic minority groups or sexual and gender minority groups.",{"count":82,"type":21},144,"OBSERVATIONAL","This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial\u002Fethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) \u002FOropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC\u002FOPSCC prevention.",[86,35,32],"HIV Infections",[88,89,90,91,92],"Health Equity","Focus Group","Sexual and Gender Minority","People living with HIV","HPV, human papillomavirus","RECRUITING","2026-06-16",{"date":96,"type":52},"2026-06-18",{"date":98,"type":52},"2025-02-13",{"date":100,"type":21},"2029-11-30",{"name":102,"class":103},"University of California, San Francisco","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":60},"100641702","clinical-evaluation-of-patient-specific-3d-printed-titanium-implants-for-facial-reconstruction-100641702","NCT07654647","Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.","Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study","3DFACE","Inclusion Criteria:\n\n* Age 18 years or older.\n* Presence of facial bone defects resulting from cystic or tumoral osteolytic lesions.\n* Acquired or congenital facial deformities associated with bony defects or facial asymmetry.\n* Patients requiring patient-specific 3D-printed titanium implants for maxillofacial reconstruction.\n* Aesthetic indications requiring custom facial implant design, including microgenia (chin retrusion).\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Active pathological lesions at the time of enrollment.\n* Age below 18 years.\n* History of radiotherapy within 12 months prior to enrollment.\n* Chronic untreated vitamin D deficiency.\n* Uncontrolled diabetes mellitus.\n* Inability or unwillingness to comply with follow-up requirements.","60 Years",{"count":114,"type":21},30,[116],"NA","This clinical study aims to evaluate the effectiveness of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects. The study will include patients presenting with congenital, traumatic, or post-surgical facial deformities requiring reconstructive intervention.\n\nEligible participants will undergo preoperative clinical assessment and radiological imaging to design customized implants using computer-aided design (CAD) and 3D printing technology. The implants will be fabricated from medical-grade titanium and surgically placed according to standardized maxillofacial reconstructive protocols.\n\nPostoperative follow-up will assess functional outcomes, implant stability, complication rates, and aesthetic improvement over a defined observation period. Outcome evaluation will include clinical examination and patient-reported satisfaction measures.\n\nThe objective of this study is to determine whether patient-specific 3D-printed titanium implants provide reliable functional restoration and improved aesthetic outcomes in facial reconstruction compared to conventional reconstructive techniques.",[119,120,35,121,122,123],"Hemifacial Microsomia","Mucormycosis","Microgenia","Facial Asymmetry","Fibrous Dysplasia",[125],"3D-Printed Titanium Implant * Facial Reconstruction","2026-06-11",{"date":128,"type":52},"2026-06-17",{"date":130,"type":52},"2026-04-26",{"date":132,"type":21},"2026-11-01",{"name":134,"class":103},"Tishreen University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":60},"100564291","phase-2-antibiotic-treatment-effects-on-intratumoral-bacteria-modulation-in-surgical-patients-with-oral-cancer-100564291","NCT06627270","Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer","A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma of the oral cavity\n* Must have planned surgery for curative intent\n* Participants ≥ 18 years of age\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known allergy to metronidazole and\u002For chlorhexidine\n* Severe liver or kidney disease as determined by history of laboratory tests\n* Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)\n* Recurrent oral cancer after prior radiation or chemoradiation\n* Participants with unresectable oral cancer\n* Participants unable to tolerate oral rinse or unable to have metronidazole administered by mouth or by feeding tube\n* Participants currently or have taken other antibiotics within the prior 30 days\n* Participant is pregnant",{"count":114,"type":21},[25],"The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.",[35,146,28,147],"Oral Cancer","Head and Neck Carcinoma",[149,150],"Metronidazole","Chlorhexidine","2026-06-03",{"date":153,"type":52},"2026-06-04",{"date":155,"type":52},"2025-03-11",{"date":157,"type":21},"2027-10-01",{"name":159,"class":103},"Case Comprehensive Cancer Center",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":177,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":60},"100500045","epigenetic-biomarkers-in-the-saliva-for-the-diagnosis-of-squamous-cells-carcinoma-of-the-oral-cavity-100500045","NCT05791149","Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity","EPSACO","Inclusion Criteria:\n\n* Patient group:\n* Patients from the maxillofacial surgery department treated for a histologically confirmed squamous cell carcinoma of the oral cavity\n* Patients whose first-line treatment decision at the multidisciplinary meeting in the service of Maxillofacial Surgery is surgery\n* Patients who have not yet been treated surgically or by neoadjuvant treatment\n* Patients over 18 years old\n* Patients who have provided free and informed consent in writing\n* Patients benefiting from a social security scheme\n\nControl group:\n\n* Patients in the maxillofacial surgery department not covered for head and neck cancer\n* Patients over 18 years old\n* Patients who have provided free and informed consent in writing\n* Patients benefiting from a social security scheme\n* Control group homogeneous with the patient group according to age, sex, tobacco and alcohol consumption\n\nExclusion Criteria:\n\n* Patients with other types of cancer\n* Patients under the age of 18\n* Pregnant or breastfeeding women\n* Patients under guardianship, curators, legal protection or deprived of liberty",{"count":168,"type":21},60,[116],"Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. The Hauts de France region has one of the highest incidence rates of OSCC. The overall survival of patients with OSCC remains low, with a 5-year overall survival rate of around 60%. In addition to the oncological prognosis, OSCCs and their treatment have a significant impact on the quality of life of patients. An early diagnosis of OSCC is recommended, but it remains difficult. It can be for example challenging to diagnose OSCC in a context of oral premalignant lesions. Identifying objective biomarkers of malignancy would be an advantage and would allow better progress in the field of precision medicine and surgery for these tumors.\n\nThe investigators propose to establish the diagnostic use of an optimized DNA methylation profile detected in the saliva of OSCC patients by comparing these epigenetic marks before and after tumor resection.\n\nThe investigators will construct a consolidated signature of 4 genes whose DNA is subject to methylation and gene expression is restricted to cancer cells, by crossing TCGA analysis with single-cell analysis (single-cell RNA sequencing).\n\nThe investigators propose to analyse DNA methylation of the corresponding genes in the saliva of n=30 OSCC patients recruited for primary surgical resection in the Department of Maxillofacial Surgery vs controls. In addition, the investigators will examine the methylation profiles before \u002F after complete excisional surgery of OSCC. This pilot study will aim to validate the analysis of DNA methylation markers in saliva of OSCC, with the aim of improving the diagnostic precision of OSCC and, secondly, to compare these markers before and after treatment by primary surgery.",[35,172,173,174,175,176],"Maxillo-facial Surgery","Biomarkers","Saliva","DNA Methylation","Epigenetics",[35,178,173,174,175,179],"Maxillo-facial surgery","epigenetics","2026-05-12",{"date":182,"type":52},"2026-05-13",{"date":184,"type":52},"2022-03-03",{"date":186,"type":21},"2027-10",{"name":188,"class":103},"Centre Hospitalier Universitaire, Amiens",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":213},"100507937","phase-2-a-study-evaluating-the-safety-and-efficacy-of-prv111-prv211-and-prv131-in-subjects-with-oral-and-lung-cancers-100507937","NCT05893888","A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers","A Phase 1\u002F2\u002F3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers","Different diagnosis for ARM 1 \\& ARM 2, however the rest of inclusion criteria are the same for both arms:\n\nIn order to be eligible to participate in the study, an individual must meet all of the following criteria:\n\n• Diagnosis Arm 1: Pathologically proven and clinically confirmed Tis\u002FCIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx,M0 of the lip or oral cavity\n\nCriteria for Inclusion for both ARM 1 \\& ARM 2:\n\n1. Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention\n2. Adult subjects, men and women, defined by age ≥18 years at the time of screening.\n3. Tumor must be accessible, with no evidence of infection or active bleeding.\n4. Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0).\n5. Clinically and\u002For radiologically measurable tumor.\n6. Eastern Collaborative Oncology Group Performance Status of ≤2.\n7. Male and female subjects of childbearing potential must agree to use 2 methods of effective contraception from screening and for at least 30 days after the final dose of investigational product. Appropriate birth control is defined as barrier methods with spermicides, oral or parenteral contraceptives and\u002For intrauterine devices, or naturally or surgically sterile (with documentation in the subject's medical records). Postmenopausal women are defined as presenting at least 12 months' natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential must be non-lactating and have a negative serum hCG within 14 days of treatment initiation.\n8. Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.\n9. Have a life expectancy of ≥3 months.\n10. Willing and able to provide written informed consent.\n11. Able to return to study site for treatment and follow-up visits as defined in the Protocol.\n\nCriteria for Exclusion for both ARM 1 and ARM 2 (unless specified):\n\nAn individual who meets any of the following criteria will be excluded from participation in the study:\n\n1. Subjects that are not eligible for surgery as SOC.\n2. Patients with a prior history of invasive squamous cell carcinoma (Arm 1 only)\n3. Tumors involving the marginal gingiva (Arm 1 only)\n4. Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy.(Arm 1 only)\n5. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)\n6. Concurrent documented malignancy, with the exception of localized SCCs and basal cell carcinoma of the skin Exposure to any investigational agent within 3 months prior to Screening\n7. Known allergy or hypersensitivity to platinum-containing agents, or known intolerance to a prior platinum- containing agent, or to any of the excipients, which, in the judgement of the physician will preclude re- exposure to platinum-containing agent\n8. Active, uncontrolled infection requiring systemic therapy, such as but not limited to HIV, Syphilis, Hepatitis B, or Hepatitis C\n9. Uncontrolled intercurrent illness that would risk subject safety, interfere with the objectives of the Protocol, or limit subject compliance with study requirements, as determined by the Investigator\n10. Known or suspected pregnancy, planned pregnancy, or lactation\n11. Any medical or psychiatric condition that may compromise the ability to give written informed consent\n12. Known diagnosis of oral submucous fibrosis (Arm 1 only)\n13. Known diagnosis of trismus (Arm 1 only)\n\nArm 3a:\n\nInclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Age: 18 years or older at the time of screening.\n2. Diagnosis: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-N1, M0. This includes SCC of the lip with a significant mucosal component.\n3. Tumor Accessibility: Tumor must be accessible for intratumoral injection, with no evidence of active infection.\n4. Measurable Disease: Presence of clinically and\u002For radiologically measurable tumor.\n5. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n6. Life Expectancy: Estimated life expectancy of at least 3 months.\n7. Informed Consent: Ability and willingness to provide written informed consent.\n8. Compliance: Ability to return to the study site for treatment visits as defined in the protocol.\n9. Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.\n2. Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.\n3. Cardiac Function: Corrected QT interval (QTc) \\> 470 ms for women and \\> 450 ms for men.\n4. Bone Involvement: Known bone involvement by the tumor (Stage T4).\n5. Other Cancers: Diagnosis of salivary gland cancer.\n6. Prior Treatments: History of oral cancers that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.\n7. Multifocal Disease: Presence of multifocal invasive oral squamous cell carcinoma (OSCC).\n8. Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.\n9. Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug, or known intolerance to prior platinum-based therapy that would preclude re-exposure.\n10. Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.\n11. Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.\n12. Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.\n13. Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.\n\n3b: Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Age: 18 years or older at the time of screening.\n2. Diagnosis: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-T2, N0, M0.\n3. Tumor Accessibility: Tumor must be accessible for intratumoral injections via a bronchoscope, with no evidence of active infection.\n4. Measurable Disease: Presence of clinically and\u002For radiologically measurable tumor.\n5. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n6. Life Expectancy: Estimated life expectancy of at least 3 months.\n7. Informed Consent: Ability and willingness to provide written informed consent.\n8. Compliance: Ability to return to the study site for treatment visits as defined in the protocol.\n9. Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.\n2. Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.\n3. Cardiac Function: Corrected QT interval (QTc) \\> 470 ms for women and \\> 450 ms for men.\n4. Bone Involvement: Known bone involvement by the tumor (Stage T4).\n5. Other Cancers: Active concurrent malignancies that require systemic therapy.\n6. Prior Treatments: History of cancers in the lung that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.\n7. Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.\n8. Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug or known intolerance to prior platinum-based therapy that would preclude re-exposure.\n9. Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.\n10. Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.\n11. Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.\n12. Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.","100 Years",{"count":198,"type":21},40,[25,200],"PHASE3","Arm 1 ( Phase 2\u002F3 Run in ):\n\nPRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017)\n\nArm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting\n\nArm 3 (Phase 1\u002F2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable\n\nSubject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis\u002FCIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0",[35],"2026-04-20",{"date":205,"type":52},"2026-04-23",{"date":207,"type":52},"2024-11-07",{"date":209,"type":21},"2027-05-31",{"name":211,"class":212},"Privo Technologies","INDUSTRY",4,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100583416","phase-2-low-cost-screening-and-image-guided-photodynamic-therapy-pdt-of-premalignant-and-malignant-oral-lesions-100583416","NCT06876038","Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions","A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting","Subject Inclusion Criteria\n\n1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.\n2. Willing and available for follow-up for at least one year and at prerequisite time intervals.\n3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent.\n4. Karnofsky Performance Score above 80 or ECOG 0 or 1.\n5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual\n\n   * Hemoglobin level above or equal to 10%\n   * WBC \\>3000\u002Fmm3\n   * Platelets count \\>100000\u002Fmm3\n   * Total bilirubin, AST (SGOT), ALT (SGPT) \\\u003C 1.5 times the Upper Limit Normal\n   * eGFR \\> 60 ml\u002Fmin\n   * Serum Creatine less than 2 times the Upper Limit of laboratory normal\n   * INR\u002F PT and PTT within laboratory normal limits\n\nExclusion criteria:\n\n1. Hypersensitivity against active substances and porphyrins.\n2. Known diagnosis of porphyria.\n3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).\n4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.\n5. Subjects with inherited or acquired bleeding and clotting disorders\n6. Women who are breastfeeding\u002F have a positive urine pregnancy test or are planning their family.\n7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.\n8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.\n9. Patients with behavioral and cognitive impairment.\n10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.\n11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.\n12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.\n13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.","65 Years",{"count":223,"type":21},65,[25],"The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a \"Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:\n\n* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?\n* Do lesions recur after PDT treatment?\n* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?",[146,227,228,229,35],"Oral Cavity Cancer","Oral Leukoplakia","Oral Lichen Planus",[231,232,233,234],"High grade dysplasia (HGD)","Severe\u002FModerate dysplasia","Carcinoma-in-situ (CIS)","Oral potentially malignant lesion (OPML)","2026-03-16",{"date":237,"type":52},"2026-03-19",{"date":239,"type":21},"2026-09",{"date":241,"type":21},"2028-12",{"name":243,"class":103},"University of Massachusetts, Boston",2,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":60},"100541982","ultra-high-frequency-intraoral-ultrasonography-of-the-tongue-houston-100541982","NCT06336941","\"Ultra-High Frequency intraOral UltraSonography of the TONgue\" (HOUSTON)","Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions","HOUSTON","Inclusion Criteria:\n\n* Clinical diagnosis of oral squamous cell carcinoma\n* Eligibility for surgical treatment\n* Acceptance to be included in the study\n\nExclusion Criteria:\n\n* Oral lesions other than oral squamous cell carcinoma\n* Pregnant or breastfeeding patients\n* Uncontrolled chronic diseases and\u002For conditions hindering the participation in the study\n* Denial of inclusion in the study",{"count":254,"type":21},400,[116],"Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.\n\nIn the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.",[35],[259,260,261],"oral neoplasm","ultrasonography","depth of invasion","2026-02-24",{"date":264,"type":52},"2026-02-25",{"date":266,"type":52},"2018-06-07",{"date":268,"type":21},"2030-12-31",{"name":270,"class":103},"University of Pisa",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":292,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100597801","phase-2-a-study-of-sacituzumab-govitecan-in-combination-with-cetuximab-in-people-with-head-and-neck-squamous-cell-cancer-hnscc-100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":198,"type":21},[25],"The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[282,283,284,227,285,286,287,35,288,289,290,291],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oropharynx Cancer","Hypopharynx Cancer","Larynx Cancer","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[282,283,284,227,285,286,287,35,288,289,290,291,293,294,295],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":298,"type":52},"2026-02-19",{"date":300,"type":52},"2025-07-02",{"date":302,"type":21},"2028-01-02",{"name":295,"class":103},7,{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":60},"100619334","dual-energy-ct-vs-mri-in-the-evaluation-of-squamous-cell-carcinomas-of-the-oral-cavity-and-oropharynx-100619334","NCT07343271","Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx","DECT-CEco","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy\n* having undergone a clinical examination with nasofibroscopy by an ENT surgeon specializing in cancer surgery\n* a contrast-enhanced cervicofacial MRI\n* and a contrast-enhanced cervicofacial DECT with BOLT maneuver.\n\nExclusion Criteria:\n\n* A lesion other than oral or oropharyngeal squamous cell carcinoma\n* A labial location\n* A contraindication to performing one or both of the imaging examinations.",{"count":114,"type":21},"The diagnostic and pre-therapeutic assessment of squamous cell carcinomas requires a neck and chest CT scan and a neck and facial MRI, which is the most effective examination, to establish the TNM stage of the tumor. However, obtaining this complete assessment can delay treatment. Confirmation of the non-inferiority of 40keV dual-energy CT in BOLT compared to MRI would spare the patient an additional MRI examination, speed up the pre-treatment assessment, reduce the loss of opportunity due to delayed treatment, and free up MRI imaging slots, which are still insufficient in the region.",[35,32],[35,32,316],"TNM stage of the tumor","2026-01-06",{"date":319,"type":52},"2026-01-15",{"date":321,"type":52},"2025-07-11",{"date":323,"type":21},"2026-07-11",{"name":325,"class":103},"University Hospital, Strasbourg, France",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":60},"100540758","systematical-trained-learning-algorithms-for-oral-carcinogenesis-interpretation-by-optical-coherence-tomography-100540758","NCT06321003","SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography","Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer","SYMILIS OCT","Inclusion Criteria:\n\n1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).\n2. Patients able to provide informed consent for participation in the study.\n3. Availability of complete clinical data and medical records.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of OSCC\u002FOPMDs and\u002For who have already undergone treatment.\n2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.\n3. Pregnant or breastfeeding women.\n4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.","99 Years",{"count":336,"type":21},200,"This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.\n\nThe trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.\n\nFurthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.\n\nIn summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.",[35,339,228,340,229,341,342,343,344,345,146,346],"Oral Potentially Malignant Disorder","Proliferative Verrucous Leukoplakia","Oral Lichenoid Lesion","Graft-versus-host-disease","Oral Erythroplakia","Actinic Keratoses","Actinic Cheilitis","Oral Disease","2025-05-19",{"date":349,"type":52},"2025-05-23",{"date":351,"type":52},"2024-03-13",{"date":353,"type":21},"2028-04-01",{"name":355,"class":103},"University of Palermo",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":60},"100535975","phase-3-neoadjuvant-immunochemotherapy-for-laoscc-100535975","NCT06258811","Neoadjuvant Immunochemotherapy for LAOSCC","Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)\n3. Primary tumor with a clinical stage of III\u002FIVA (T1-2\u002FN1-2\u002FM0 or T3-4a\u002FcN0-2\u002FM0, AJCC 2018)\n4. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n5. Blood routine: white blood cells (WBCs) \\>3,000\u002Fmm3, hemoglobin \\>8 g\u002FL, platelets \\>80,000\u002Fmm3\n6. Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal\n7. Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal\n8. Coagulation function: INR、PT、APTT\\\u003C1.5 times the upper limit of normal\n9. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Unresolved grade 2 \\[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\\] or higher toxic reactions caused by previous anticancer treatments\n2. Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy\n3. Known history of malignancy, unless been cured and no recurrence for 5 years\n4. Known history of radiation to head and neck\n5. Active severe clinical infection (\\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)\n6. Obvious cardiovascular abnormalities \\[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\\]\n7. Patients receiving immunology-based treatment for any reason\n8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n9. Pregnant or lactating women\n10. Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU\u002FmL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)\n11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation\n12. Participation in other clinical trials within 30 days before enrollment\n13. Other situations that the investigator considers unsuitable with respect to participating in the trial","75 Years",{"count":365,"type":21},134,[200],"To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.",[35,369],"Locally Advanced Head and Neck Carcinoma",[371,372],"Oral squamous cell carcinoma","Neoadjuvant immunochemotherapy","2025-03-10",{"date":375,"type":52},"2025-03-13",{"date":377,"type":52},"2024-02-20",{"date":379,"type":21},"2028-12-30",{"name":381,"class":103},"Lai-ping Zhong",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":244},"100529488","validity-of-viomes-oralthroat-cancer-test-100529488","NCT06174428","Validity of Viome's Oral\u002Fthroat Cancer Test","Validity of Viome's Oral\u002Fthroat Cancer Test Among Patients with a Suspicion of Cancer","Inclusion Criteria:\n\n* Signed and dated informed consent prior to any study-specific procedures are performed\n* Willing and able to follow the study instructions, as described in the recruitment letter\n* Adults (18 years old or older)\n* Suspicion of OSCC or OPSCC on clinical presentation by a clinician\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of fertility enhancing medications",{"count":390,"type":21},1000,"A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.",[393,32,35],"Oral and Throat Cancer",[395,396,146,397,398],"OSCC","OPSCC","Throat cancer","Oral and Throat cancer","2025-01-27",{"date":401,"type":52},"2025-01-29",{"date":399,"type":52},{"date":404,"type":21},"2026-12",{"name":406,"class":212},"Viome",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":414,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":60},"100473931","detection-of-oral-and-throat-cancers-using-oralviome-cancer-testing-system-100473931","NCT05451303","Detection of Oral and Throat Cancers Using OralViome Cancer Testing System","Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis","Inclusion Criteria\n\n* Signed Informed Consent obtained\n* 18 years and older\n* At a high risk of developing oral or throat cancer based on clinician's discretion\n\nExclusion Criteria\n\n* Pregnancy\n* Use of fertility enhancing medications",true,{"count":416,"type":21},475,"To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.",[35,288,419],"Premalignant Lesion",[406,421,422,395,423,424,425,426,427,428],"oral cancer","detection","OPMD-B","OPMD-PM","OPMD","OPV","Tobacco","HPV",{"date":401,"type":52},{"date":431,"type":52},"2022-05-27",{"date":404,"type":21},{"name":406,"class":212},{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":450,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":60},"100494561","tolerance-and-benefits-of-mandibular-advanced-device-for-snoring-and-sleep-apnea-in-oropharyngeal-cancer-100494561","NCT05719779","Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer.","Evaluation of the Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Patients With Oropharyngeal Cancer: Mixed Design Study.","Ronco-Onco","Inclusion Criteria:\n\n* oropharyngeal cancer diagnosis\n* 18 years of age and over\n* female or male; ratio of 1\u002F4 toward men\n* had received RTH in the Department of Radiation Oncology,\n* reporting snoring and\u002For respiratory cessation complaints during sleep,\n\nExclusion Criteria:\n\n* pregnant or breastfeeding woman;\n* edentation preventing retention of the oral appliance;\n* taking opioid or anxiolitic type medications;\n* history of major depression,\n* uncontrolled hypertension,\n* history of stroke;\n* under treatment with CPAP for sleep apnea;\n* regular and intense orofacial pain;\n* under pharmacological treatment for insomnia;\n* excessive alcohol or drug use (e.g., cannabis, opioid).",{"count":443,"type":21},35,[116],"Evaluation of the Tolerance and Benefits of Mandibular Advanced Device (MAD) for Snoring and Sleep Apnea in Patients with Oropharyngeal Cancer (OPC): Mixed Design Study.",[146,447,448,449,35],"Pharynx Cancer","Sleep Apnea","Snoring",[451,452,453,454],"oropharyngeal cancer","snoring","sleep apnea","oral appliance","2024-08-14",{"date":457,"type":52},"2024-08-15",{"date":459,"type":52},"2023-02-03",{"date":461,"type":21},"2025-12-30",{"name":463,"class":103},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":60},"100549814","nbi-for-early-diagnosis-of-opmdoscc-100549814","NCT06438939","NBI for Early Diagnosis of OPMD\u002FOSCC","Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)","NBI_Oral","Inclusion Criteria:\n\n* Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1);\n* Patients with history OPMD (clinically evident lesion\u002Fs group 2a, lesion\u002Fs excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion);\n* Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b);\n* High risk (see above) individuals with no known oral mucosal disease (group 4);\n\nExclusion Criteria:\n\n* patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I)\n* patients who, despite indication, were not suitable to undergo biopsy given his \u002F her systemic conditions",{"count":473,"type":21},480,[116],"Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC\u002FOPMD. We thus propose a randomised clinical trial understand its role in this field.",[35,339],[478,395,425,479],"narrow band imaging","NBI","2024-05-27",{"date":482,"type":52},"2024-06-03",{"date":484,"type":21},"2024-09-30",{"date":486,"type":21},"2026-12-31",{"name":488,"class":103},"Cardarelli Hospital",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"100500633","phase-3-neoadjuvant-anti-pd-1-immunotherapy-with-chemotherapy-in-resectable-locally-advanced-oral-squamous-cell-carcinoma-100500633","NCT05798793","Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma","A Multi-Center, Randomized Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Up-Front Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma","NEOPCOSCC","Inclusion Criteria:\n\n1. Histologically documented oral squamous cell carcinoma (biopsy required).\n2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.\n3. Distant metastasis is excluded by chest CT and emission computed tomograph.\n4. Adequate organ function as follows: 1) Leukocyte count ≥ 2,000\u002Fmm3; 2) Absolute neutrophil count ≥ 1,000\u002Fmm3; 3) Platelet count ≥ 100,000\u002Fmm3; 4) Hemoglobin ≥ 90 g\u002FL; 5) Serum albumin ≥30 g\u002FL; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR\u002FPT≤ 1.5; 12) TSH ≤ ULN.\n5. ECOG performance status 0-1.\n6. Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade.\n7. Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.\n2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.\n3. Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.\n4. Active autoimmune disease or history of refractory autoimmune disease.\n5. Active systemic infection requiring therapy.\n6. Patients who are receiving psychotropic drug or alcohol\u002Fdrug abuse.\n7. Subjects with concurrent other active malignancies.\n8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.\n9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.\n10. History of stroke or transient ischemic attack within past 6 months.\n11. Distant metastases or inability to resect after physician evaluation.\n12. Serious cardiovascular, respiratory, immune system critical disease or other conditions that the researchers thought might increase the subjects' risk.","70 Years",{"count":499,"type":21},309,[200],"The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.",[35],[504,371,505,506,507],"Neoadjuvant","Anti-PD-1 immunotherapy","Camrelizumab","TP chemotherapy","2024-04-01",{"date":510,"type":52},"2024-04-02",{"date":512,"type":52},"2023-11-21",{"date":514,"type":21},"2026-10-01",{"name":516,"class":103},"Hospital of Stomatology, Wuhan University",3,{"id":519,"slug":520,"hasResults":11,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":60},"100446798","phase-2-neoadjuvant-sintilimab-combined-with-reduction-of-cycles-of-chemotherapy-in-resectable-oral-cavity-or-oropharyngeal-squamous-cell-carcinoma-ooc-002-100446798","NCT05098119","Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)","Phase II Trial of Sintilimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Reduction of Cycles of Chemotherapy, as a Novel Neoadjuvant Pre-Surgical Therapy for Oral Cavity or Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Have a histologically confirmed diagnosis of OSCC or OPSCC which is planned for treatment with curative intent including surgical resection.\n* Greater than or equal to 18 and less than 80 years of age at time of study entry.\n* ECOG performance status of 0 or 1.\n* Measurable disease as per RECIST 1.1.\n* Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.\n* Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:\n\n  1. Adequate hepatic and renal function as demonstrated by\n\n     1. Serum creatinine \\\u003C 1.5 X ULN or CrCl \\> 40mL\u002Fmin (if using the Cockcroft-Gault formula below):\n\n        * Males: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL)）\n        * Females: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL))x 0.85\n     2. AST\u002FALT ≤ 3 x ULN\n     3. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  2. Adequate bone marrow function as demonstrated by:\n\n     1. Absolute Neutrophil Count \\>1,500\u002FµL\n     2. Platelets \\> 100 X 103\u002FµL\n     3. Hemoglobin \\> 9.0 g\u002FdL\n* Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 21 days of study enrollment.\n* Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; \"women of reproductive potential\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n* Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had another known invasive malignancy within the previous 5 years and\u002For has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.\n* If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.\n* Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger .\n* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.\n* A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B or C.\n* Known history of active TB ( bacillus tuberculosis ).","80 Years",{"count":527,"type":21},43,[25],"The study is being conducted to evaluate the efficacy and safety of sintilimab in combination with reduction of cycles of chemotherapy (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in oral cavity or oropharyngeal squamous cell carcinoma.",[531,35,32],"Oral Cavity Squamous Cell Carcinoma","2024-03-24",{"date":534,"type":52},"2024-03-26",{"date":536,"type":52},"2021-09-16",{"date":538,"type":21},"2028-09-16",{"name":540,"class":103},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":60},"100448868","phase-2-neoadjuvant-anti-pd-1-and-tp-versus-tpf-on-pathological-response-in-oscc-100448868","NCT05125055","Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC","Neoadjuvant Toripalimab and Albumin Paclitaxel \u002FCisplatin Versus Docetaxel\u002F Cisplatin\u002F 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age: 18-75 years old\n2. Gender: male and female\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2\n4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)\n5. Primary tumor with a clinical stage of III\u002FIVA (T1-2\u002FN1-2\u002FM0 or T3-4a\u002FcN0-2\u002FM0, AJCC2018)\n6. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n7. Blood routine: white blood cells (WBCs) \\>3,000\u002Fmm3, hemoglobin \\>8 g\u002FL, platelets \\>80,000\u002Fmm3\n8. Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal\n9. Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal\n10. Coagulation function: INR, PT, APTT\\\u003C1.5 times the upper limit of normal\n11. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Unresolved grade 2 \\[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\\] or higher toxic reactions caused by previous anticancer treatments\n2. Known allergic reaction to any ingredients or excipients of the therapy\n3. Known history of malignancy, unless been cured and no recurrence for 5 years\n4. Known history of radiation to head and neck\n5. Active severe clinical infection (\\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)\n6. Obvious cardiovascular abnormalities \\[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\\]\n7. Patients receiving immunology-based treatment for any reason\n8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n9. Pregnant or lactating women\n10. Uncontrollable hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment\n11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation\n12. Participation in other clinical trials within 30 days before enrollment\n13. Other situations that the investigator considers unsuitable with respect to participating in the trial",{"count":549,"type":21},80,[25,200],"To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel \u002FCisplatin (TTP) with Docetaxel\u002F Cisplatin\u002F 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.",[35,553,554,43],"Neoadjvant Therapy","Anti-PD-1",{"date":556,"type":52},"2023-11-22",{"date":558,"type":52},"2021-10-01",{"date":560,"type":21},"2026-12-30",{"name":562,"class":103},"Shanghai Jiao Tong University School of Medicine",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":60},"100444624","phase-2-neoadjuvant-personalized-anti-pd-1-and-anti-vegfr-therapy-in-oscc-patients-100444624","NCT05069857","Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients","Neoadjuvant Personalized Anti-PD-1 Therapy With Combination of Anti-VEGFR Therapy in Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Randomized Controlled Phase II Trial","Inclusion Criteria:\n\n1. Age: 18 to 75\n2. Gender: Male and female\n3. ECOG Score: 0-2\n4. Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)\n5. Clinical stage III\u002FIVA (cT1-2\u002FN1-2\u002FM0 or cT3-4a\u002FN0-2 \u002FM0, AJCC 8th)\n6. The combined positive score (CPS score) of PD-L1 expression \\> 10\n7. Has signed informed consent\n\nExclusion Criteria:\n\n1. Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy\n2. Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)\n3. Active severe clinical infection (\\> NCI-CTCAE Version 5.0 level 2 infection)\n4. Uncontrollable hypertension (systolic blood pressure \\> after antihypertensive medication; 150mmHg and\u002For diastolic blood pressure \\> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (≤ 6 months before screening), myocardial infarction (≤ 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment\n5. Blood routine examination: WBC \\\u003C 3,000\u002Fmm3, hemoglobin \\\u003C 8g\u002FL, platelet \\\u003C 80,000\u002Fmm3\n6. Liver function: ALAT\u002FASAT \\> 2.5 times the normal upper limit, bilirubin \\> 1.5 times the normal upper limit\n7. Renal function: serum creatinine \\> 1.5 times the normal upper limit\n8. Has a history of maxillofacial and neck radiotherapy\n9. Pregnant or lactating women\n10. Participation in other clinical studies within 30 days prior to enrollment\n11. Other conditions that the investigator considers inappropriate for participation",{"count":571,"type":21},46,[25],"To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\\>10 in the biopsy samples.",[35,553,554,575],"Anti-VEGFR",{"date":556,"type":52},{"date":578,"type":52},"2021-09-01",{"date":580,"type":21},"2028-06-30",{"name":562,"class":103},{"id":583,"slug":584,"hasResults":11,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":60},"100505498","phase-2-neoadjuvant-treatment-of-tislelizumab-combined-chemotherapy-for-locally-advanced-oral-squamous-cell-carcinoma-a-single-arm-prospective-phase-ii-trial-100505498","NCT05862168","Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial","Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective，Phase II Study","Inclusion Criteria:\n\n1. Signed the informed consent form\n2. Histopathological diagnosis of oral squamous cell carcinoma\n3. Age: 18-75 years old , Gender: male and female\n4. Primary tumor with a clinical stage of III\u002FIVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n6. No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);\n7. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n8. Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) \\>3.0× 109\u002FL, ANC \\>1.5× 109\u002FL, platelets \\>75× 109\u002FL, hemoglobin \\>9 g\u002FL, 2）Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal，3）Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal，4）Coagulation function: INR, PT, APTT\\\u003C1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF) ≥ 50%\n9. contraception\n\nExclusion Criteria:\n\n1. Known history of malignancy, unless been cured and no recurrence for 5 years\n2. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n3. Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck\n4. Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.\n5. Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.\n6. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.\n7. Serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose.\n8. Known human immunodeficiency virus (HIV) infection\n9. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies\u002Fml \\[200 IU\u002Fml\\] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection).\n10. History of pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroids or current pneumonitis.\n11. Known allergic reaction to any ingredients or excipients of the therapy\n12. Participation in other clinical trials within 30 days before enrollment\n13. Pregnant or lactating women\n14. Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial",{"count":114,"type":21},[25],"TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.",[35],"2023-07-14",{"date":595,"type":52},"2023-07-17",{"date":597,"type":52},"2023-05-08",{"date":580,"type":21},{"name":600,"class":103},"Weijia Fang, MD",{"id":602,"slug":603,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":608,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":60},"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.",{"count":609,"type":21},124,"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.",[35,612],"Locally Advanced Head and Neck Squamous Cell Carcinoma","2023-05-14",{"date":615,"type":52},"2023-05-24",{"date":617,"type":52},"2022-04-01",{"date":239,"type":21},{"name":620,"class":103},"Xiangya Hospital of Central South University",{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":363,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":4},"100501193","elective-vs-therapeutic-neck-dissection-in-treatment-of-patients-with-clinical-t12n1m0-oral-squamous-cell-carcinoma-100501193","NCT05806073","Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1\u002F2N1M0 Oral Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth;\n2. No history of chemotherapy, radiotherapy or targeted therapy,for any reason before\n3. No history of a prior malignancy in head and neck region\n4. No history of a prior malignancy outside head and neck region in the preceding 5 years\n5. Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;\n6. Participants will be reliable for follow-up\n7. Understanding the protocol and is able to give informed consent\n\nExclusion Criteria:\n\n1. failed to obtain the signed written informed consent;\n2. definite distant metastasis or other malignant tumor;\n3. Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy);\n4. previously received radiotherapy for primary tumors or lymph nodes;\n5. previously received anti-tumor biological targeted therapy;\n6. Chemotherapy or immunotherapy has been applied to the primary tumor in the past;\n7. Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)；\n8. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred in the first 12 months, serious arrhythmia requiring medical treatment, liver, kidney or metabolic diseases);\n9. known human immunodeficiency virus (HIV) infection;\n10. chronic diseases requiring immune preparations or hormone treatment;\n11. pregnant or lactating women;\n12. drug\u002Falcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance;\n13. Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs);\n14. participated in other clinical trials in the past 30 days;\n15. cases that the researcher thinks are not suitable for joining the group.",{"count":628,"type":21},188,[116],"Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from \"excessive dissection of area of IV and V\".\n\nBoth the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.",[35,632],"Neck Dissection","2023-04-10",{"date":635,"type":52},"2023-04-12",{"date":637,"type":21},"2023-04",{"date":404,"type":21},{"name":640,"class":103},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"]