[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital of Stomatology, Wuhan University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,80],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100646300","early-warning-and-risk-prediction-of-medication-related-osteonecrosis-of-the-jaw-100646300",false,"NCT07691892","Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw","Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.","Inclusion Criteria:\n\n1. Adults aged 18 to 70 years, regardless of sex.\n2. Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases.\n3. Continuous use of bone-modifying agents for at least 24 months before enrollment.\n4. Scheduled to undergo clinically indicated invasive oral procedures, including root canal therapy, periapical surgery, tooth extraction, periodontal scaling and root planing, periodontal surgery, or other invasive oral procedures as clinically needed.\n5. No clinical signs of medication-related osteonecrosis of the jaw before the planned oral procedure, according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons.\n6. Able to understand the study purpose and procedures and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Previously diagnosed or suspected medication-related osteonecrosis of the jaw.\n2. Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw.\n3. Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures.\n4. Severe cardiac, hepatic, or renal dysfunction, including New York Heart Association class III-IV heart failure, Child-Pugh class C liver disease, or renal failure requiring dialysis.\n5. Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment.\n6. Salivary gland dysfunction, such as Sjögren's syndrome, that may affect the quality of saliva sample collection.\n7. Pregnancy or breastfeeding.\n8. Psychiatric disorders or cognitive impairment that would prevent understanding of the study procedures or compliance with follow-up.\n9. Uncontrolled hypertension or diabetes mellitus, or a history of stroke or transient ischemic attack within the past 6 months.\n10. Use of any vaccine for the prevention of infectious diseases, such as influenza or varicella vaccine, within 4 weeks before enrollment.\n11. Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis B or hepatitis C infection. Active hepatitis B is defined as HBV DNA above the upper limit of normal, and active hepatitis C is defined as HCV viral titer or RNA above the upper limit of normal.\n12. Participation in another clinical study that may interfere with the results of this study.","ALL","18 Years","70 Years",{"count":20,"type":21},310,"ESTIMATED","12 Months","OBSERVATIONAL","This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion.\n\nEligible participants will include adults who have received bone-modifying agents, including bisphosphonates or denosumab, for at least 24 months for osteoporosis or bone metastases and who are scheduled to undergo clinically indicated invasive oral procedures. The study will not assign any treatment or intervention. All oral procedures will be performed as part of routine clinical care.\n\nClinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging data, and biological samples including saliva, blood, urine, and gingival crevicular fluid will be collected. Proteomic and metabolomic analyses will be performed to identify candidate biomarkers associated with MRONJ risk.\n\nParticipants will be followed prospectively after the oral procedure to assess wound healing, clinical symptoms, imaging changes, and the occurrence of MRONJ. The study will evaluate whether a multimodal model combining clinical, imaging, and biological data can predict the risk of MRONJ after invasive oral procedures.",[26],"Medication-related Osteonecrosis of the Jaw (MRONJ)",[28,29,30,31,32,33,34,35,36,37],"medication-related osteonecrosis of the jaw (MRONJ)","Bone-modifying agents","Bisphosphonates","Denosumab","Invasive oral procedures","Risk prediction","Multimodal data fusion","Proteomics","Metabolomics","Biomarkers","NOT_YET_RECRUITING","2026-07-02",{"date":41,"type":42},"2026-07-09","ACTUAL",{"date":44,"type":21},"2026-08-01",{"date":46,"type":21},"2030-09-01",{"name":48,"class":49},"Hospital of Stomatology, Wuhan University","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100537435","phase-2-the-combination-of-adebrelimab-and-tp-regimen-for-neoadjuvant-therapy-in-patients-with-stage-ivb-oral-squamous-cell-carcinoma-100537435","NCT06277791","The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma","A Single Arm, Exploratory Clinical Study of the Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma in Clinical Practice","Inclusion Criteria:\n\n1. Oral squamous cell carcinoma patients diagnosed by histology or cytology;\n2. Has not received any treatment for oral squamous cell carcinoma in the past;\n3. According to the AJCC TNM staging system, stage clinical IVB;\n4. ECOG score: 0-1 points;\n5. Expected survival time ≥ 12 weeks;\n6. The main organ function is good, and the laboratory test data meets the following standards: (1) Blood routine: Absolute neutrophil count ≥ 1.5 × 109\u002FL (or greater than the lower limit of normal values in the research center laboratory), platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 90g\u002FL; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times the ULN. If the patient has liver metastasis, this standard is ≤ 5 times the ULN; (3) Renal function: CrCl ≥ 60 ml\u002Fmin\u002F1.73 m2 (calculated according to Cockcroft Gault formula);\n7. Female participants with fertility, as well as male participants with partners who are fertile women, are required to use a medically recognized contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period, and at least 6 months after the last use of adelbizumab and at least 6 months after the last use of chemotherapy;\n8. Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There are uncontrollable pleural effusion, pericardial effusion, or abdominal effusion that require repeated drainage;\n2. Have a history of allergies to any components of adelbizumab in the past;\n3. Have received any of the following treatments:\n\n   1. Received any other investigational medication within 4 weeks prior to the first use of the investigational medication, or had a half-life of no more than 5 weeks from the last investigational medication;\n   2. Simultaneously enroll in another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up;\n   3. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;\n   4. Subjects who need to receive corticosteroids (\\>10mg prednisone equivalent dose per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortex hormone replacement with a dose greater than 10mg\u002Fday of prednisone efficacy dose;\n   5. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug;\n   6. Having undergone major surgery or severe trauma within 4 weeks prior to the first use of the investigational drug;\n   7. Patients who have previously received treatment with paclitaxel drugs;\n4. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 level 1 (excluding hair loss) or the level specified by the inclusion\u002Fexclusion criteria;\n5. A history of active autoimmune diseases and autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding patients with vitiligo or childhood asthma\u002Fallergies who have already recovered and do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;\n6. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU\u002Fml or 2500 copies\u002FmL);\n7. The subjects have uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;\n8. Serious infections (CTCAE 5.0\\>Level 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications that require hospitalization treatment; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics;\n9. History of interstitial lung disease (excluding radiation pneumonia and non infectious pneumonia that have not been treated with steroids);\n10. Patients who have been diagnosed with active pulmonary tuberculosis infection through medical history or CT examination, or have a history of active pulmonary tuberculosis infection within one year before enrollment, or have a history of active pulmonary tuberculosis infection more than one year before but have not received formal treatment;\n11. Diagnosed with any other malignant tumor within the 5 years prior to the first use of the investigational drug, excluding malignant tumors with low risk of metastasis and mortality (5-year survival rate\\>90%), such as basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been adequately treated;\n12. Pregnant or lactating women;\n13. According to the researcher\\'s judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormalities in laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.","75 Years",{"count":59,"type":21},35,"INTERVENTIONAL",[62],"PHASE2","The goal of this \\[type of study:clinical trial\\] is to \\[learn about\\] in \\[Clinical IVB stage oral squamous cell carcinoma patients\\]. The main question it aims to answer are:\n\n• \\[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\\] Participants will \\[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\\'s condition, with a total follow-up of two years.\\].",[65],"Clinical IVb Stage Oral Squamous Cell Carcinomas Patients",[67,68,69],"Adebrelimab","PD-L1","Neoadjuvant therapy","RECRUITING","2025-05-28",{"date":73,"type":42},"2025-05-29",{"date":75,"type":42},"2023-08-19",{"date":77,"type":21},"2026-07-31",{"name":48,"class":49},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":88,"targetDuration":4,"studyType":60,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":5},"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.",{"count":89,"type":21},309,[91],"PHASE3","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.",[94],"Oral Squamous Cell Carcinoma",[96,97,98,99,100],"Neoadjuvant","Oral squamous cell carcinoma","Anti-PD-1 immunotherapy","Camrelizumab","TP chemotherapy","2024-04-01",{"date":103,"type":42},"2024-04-02",{"date":105,"type":42},"2023-11-21",{"date":107,"type":21},"2026-10-01",{"name":48,"class":49},""]