[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-squamous-cell-carcinoma-oscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-squamous-cell-carcinoma-oscc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,45,78,109,129,156,182,220,245,270,297,318],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632521","phase-2-evaluation-of-the-efficacy-and-safety-of-nivolumab-neoadjuvant-treatment-of-patients-with-locally-advanced-oral-squamous-cell-carcinoma-100632521",false,"NCT07514767","Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma","NOCANO: Nivolumab as Neoadjuvant Immunotherapy for Patients With Oral CANcer and Identification of Response-predictive Biomarkers in Tumour Draining Lymph NOdes","NOCANO","Inclusion Criteria:\n\n* The subject is willing to participate and has given their written and dated consent to participate in the trial.\n* Naïve to immunotherapy.\n\n  ≥ 18 years of age at the time of signing the informed consent.\n* Primary histologically or cytologically confirmed Oral Squamous Cell Carcinoma classified according to the ICD-10 classification.\n* Stage T2-4 N0-3 M0.\n* The subject is planned for curative surgery as the primary treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.\n* Active malignancy requiring concurrent treatment or history of another primary malignancy.\n* History of radio- and\u002For chemotherapy.\n* Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose.\n* History of systemic treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n* Prior organ transplantation.\n* Treatment with a live (attenuated) vaccine within 4 weeks before Screening visit.\n* Initiation of allergen immunotherapy within 3 months prior Screening visit or a plan to begin therapy during the trial.\n* Known or suspected systemic hypersensitivity to the active substance nivolumab including any of the OPDIVO™ excipients.\n* History of systemic hypersensitivity or anaphylaxis to other monoclonal antibodies including any excipient.\n* Active, known, or suspected autoimmune disease or inflammatory disease (e.g. lupus, inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\]), diverticulitis, rheumatoid arthritis, Sarcoidosis, Wegener syndrome, Grave's disease, uveitis, etc.) that has required systemic treatment with immune modifying agents in the last 2 years (e.g. replacement therapy such as thyroxine, insulin or physiological corticosteroids is not an exclusion criteria).\\*The subject may enroll if they have vitiligo, alopecia, 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* Presence of condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisolone equivalents) or other immunosuppressive medication within 14 days before the start of nivolumab therapy.\n* Severe asthma exacerbation requiring the admission to hospital with systemic corticosteroids within 4 weeks before Screening visit.\n* Known significant respiratory disease, including, but not limited to, pneumonitis, interstitial lung disease (ILD), chronic obstructive pulmonary disease, cystic fibrosis.\n* Prior history or evidence of active ILD or non-infectious pneumonitis that required steroids\n* Known or suspected condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.\n* Recent history of myocardial infarction, cardiac arrhythmia, unstable angina pectoris, transient ischemic attack, or a known history of a hypercoagulable disease.\n* Known hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) acute or chronic infection. If suspected, tests for hepatitis B surface antigen (HBs Ag) and\u002For HCV antibody (HCV Ab) confirmed by HCV ribonucleic acid (RNA) are required.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) or positive HIV 1\u002F2 serology test result if suspected.\n* Active tuberculosis (TB), non-tuberculous mycobacterial infection, a history of incompletely treated TB. TB test if suspected.\n* Known or suspected immunodeficiency, including history of invasive opportunistic infections (e.g. TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis or aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting a compromised immune system status, as judged by the Investigator.\n* Uncontrolled concurrent medical disorder affecting organ function and in the opinion of the Investigator may increase the risk for the subject or may interfere with the treatment and thus affect the study results or assessment.\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* Known or suspected heavy drinking and\u002For drug use.\n* In the opinion of the Investigator, the subject is unfit or unsuitable to receive neoadjuvant nivolumab, whatever the reason, including medical or clinical condition.\n* Any mental inability (e.g. dementia), reluctance or language difficulties that result in difficulty understanding the meaning of participation in the clinical trial and following the study protocol and instructions.\n* Lack of adherence to the study protocol and instructions given by the Investigator.\n* Premature withdrawal by the Investigator\u002FSponsor due to safety or any other reason.\n* Revoked consent.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.",[27],"Oral Squamous Cell Carcinoma (OSCC)",[29,30,31],"neoadjuvant","Nivolumab","anti-PD-1","NOT_YET_RECRUITING","2026-04-01",{"date":35,"type":36},"2026-04-07","ACTUAL",{"date":38,"type":21},"2026-05-01",{"date":40,"type":21},"2033-09",{"name":42,"class":43},"Prof. Lars Olaf Cardell","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100621514","phase-3-sintilimab-plus-chemotherapy-as-neoadjuvant-and-adjuvant-treatment-for-locally-advanced-oral-squamous-cell-carcinoma-100621514","NCT07371611","Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma","Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma: A Multicenter, Open-label, Randomized, Phase III Clinical Study","Inclusion Criteria:\n\n* Aged 18 to 75 years at the time of enrollment.\n* ECOG Performance Status (PS) score of 0-1.\n* Primary lesion pathologically confirmed as oral squamous cell carcinoma (OSCC), including tumors of the anterior two-thirds of the tongue, gingiva, buccal mucosa, floor of the mouth, hard palate, or retromolar trigone.\n* Clinical stage III or IVA, defined as T1-2 with N1-2, or T3-4a and\u002For N0-2, according to the AJCC 8th edition OSCC TNM staging system.\n* Willingness to undergo surgical treatment.\n* Presence of at least one measurable lesion as defined by RECIST v1.1 criteria.\n* Voluntary participation with full understanding and signing of the informed consent form, and willingness to comply with study procedures.\n* Adequate major organ function, meeting all of the following laboratory criteria:\n* 1\\. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without granulocyte colony-stimulating factor (G-CSF) administration within 14 days prior to testing.\n* 2\\. Platelet count ≥ 100 × 10⁹\u002FL without blood transfusion within the previous 14 days.\n* 3\\. Hemoglobin \\> 90 g\u002FL without blood transfusion or erythropoietin use within the previous 14 days.\n* 4\\. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN); ≤ 3 × ULN in cases of Gilbert's syndrome or non-hepatic indirect bilirubin elevation.\n* 5\\. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; ≤ 5 × ULN for patients with hepatic involvement.\n* 6\\. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n* 7\\. Adequate coagulation function, defined as INR or prothrombin time (PT) ≤ 1.5 × ULN.\n* 8\\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with abnormal TSH may be enrolled if total T3 (or FT3) and FT4 are within normal limits.\n* 9\\. Normal myocardial enzyme profile (minor laboratory abnormalities deemed clinically insignificant by the investigator are acceptable).\n* 10\\. For women of childbearing potential, a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1) is required. If the urine test is indeterminate, a serum test must be performed. Non-childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy.\n* 11\\. All participants (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate \\\u003C1%) during the entire treatment period and for at least 120 days after the last study drug dose or 180 days after the last chemotherapy dose.\n\nExclusion Criteria:\n\n* Prior treatment targeting PD-1, PD-L1, PD-L2, or CTLA-4, or other therapies targeting T-cell costimulatory or immune checkpoint pathways.\n* Participation in another interventional clinical trial or use of an investigational drug or device within 4 weeks prior to the first dose.\n* History of radiotherapy involving the head, neck, or maxillofacial regions.\n* Use of traditional Chinese medicines or immunomodulatory agents with OSCC indications (e.g., thymosin, interferon, interleukin) within 2 weeks before first dosing; local therapy for pleural effusion control is permitted.\n* History of active autoimmune disease within the past 2 years requiring systemic therapy (e.g., corticosteroids or immunosuppressants). Exceptions include:\n* 1\\. Hypothyroidism controlled with thyroid hormone replacement therapy.\n* 2\\. Diabetes mellitus controlled with insulin.\n* 3\\. Adrenal or pituitary insufficiency treated with physiologic doses of corticosteroids.\n* Use of immunosuppressive agents:\n* 1\\. Systemic corticosteroid therapy within 1 week prior to the first dose is prohibited.\n* 2\\. Use of other immunosuppressive drugs is prohibited.\n* 3\\. Intranasal, inhaled, or topical corticosteroids are permitted.\n* 4\\. Physiologic doses of corticosteroids (e.g., prednisone ≤10 mg\u002Fday or equivalent) are permitted.\n* Prior systemic antitumor therapy, except patients who have had ≥12 months of treatment-free interval between the last chemotherapy and initiation of neoadjuvant therapy.\n* Previous allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplantation).\n* Known hypersensitivity to sintilimab, carboplatin, cisplatin, nab-paclitaxel, or any of their excipients.\n* Failure to recover to baseline or ≤ grade 1 (except fatigue or alopecia) from adverse events or complications of prior interventions before enrollment.\n* Known human immunodeficiency virus (HIV) infection (HIV-1\u002F2 antibody positive).\n* Untreated active hepatitis B infection (HBsAg positive with HBV-DNA above the ULN). Subjects meeting the following criteria may be enrolled:\n* 1\\. HBV viral load \\\u003C1000 copies\u002FmL (200 IU\u002FmL) and receiving antiviral therapy during the study to prevent reactivation.\n* 2\\. Subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV-DNA(-) do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation.\n* Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).\n* Receipt of a live vaccine within 30 days prior to the first dose (inactivated vaccines, such as inactivated influenza vaccine, are permitted; intranasal live vaccines are not allowed).\n* Pregnant or breastfeeding women.\n* Presence of severe or uncontrolled systemic diseases, including but not limited to:\n* 1\\. Cardiac disorders: severe arrhythmias (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or persistent atrial fibrillation), unstable angina, or congestive heart failure (NYHA class ≥ II).\n* 2\\. Vascular disorders: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months before enrollment.\n* 3\\. Poorly controlled hypertension (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg).\n* 4\\. Pulmonary disorders: noninfectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or active interstitial lung disease.\n* 5\\. Infectious diseases: active infections requiring systemic treatment, or severe uncontrolled infections.\n* 6\\. Active pulmonary tuberculosis.\n* 7\\. Gastrointestinal disorders: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction.\n* 8\\. Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis.\n* 9\\. Poorly controlled diabetes mellitus: fasting blood glucose (FBG) \\>10 mmol\u002FL.\n* 10\\. Renal dysfunction: urine protein ≥++ on urinalysis and 24-hour urinary protein \\>1.0 g.\n* 11\\. Psychiatric disorders: severe mental illness that may affect treatment compliance.\n* Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.","75 Years",{"count":54,"type":21},104,[56],"PHASE3","This is a multicenter, open-label, randomized phase III clinical trial evaluating perioperative treatment with sintilimab combined with chemotherapy in patients with locally advanced oral squamous cell carcinoma.\n\nDespite standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy, patients with locally advanced oral squamous cell carcinoma remain at high risk of recurrence or metastasis. Recent evidence, including results from the KEYNOTE-689 study, suggests that perioperative immunotherapy may improve survival outcomes, and this approach has been incorporated into NCCN guidelines. Combining immunotherapy with chemotherapy may further improve prognosis in this patient population.\n\nEligible participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive neoadjuvant sintilimab combined with chemotherapy followed by surgery and postoperative treatment based on pathological response. Patients with major pathological response (MPR) will receive adjuvant sintilimab, while patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy combined with sintilimab. The control group will receive standard treatment consisting of surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated.\n\nThe primary objective of the study is to compare event-free survival between the two groups. Secondary objectives include overall survival, pathological response, safety, and treatment-related adverse events. The results of this study may help optimize perioperative treatment strategies and improve outcomes for patients with locally advanced oral squamous cell carcinoma.",[59,27],"Locally Advanced Oral Squamous Cell Carcinoma",[61,62,63,64,65,66,67],"Oral Squamous Cell Carcinoma","Locally Advanced","Sintilimab","Perioperative Immunotherapy","Neoadjuvant Therapy","Adjuvant Therapy","Randomized Phase III Trial","RECRUITING","2026-01-19",{"date":71,"type":36},"2026-01-28",{"date":73,"type":21},"2026-01-01",{"date":75,"type":21},"2033-12-31",{"name":77,"class":43},"Qunxing Li,MD",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100616510","effectiveness-of-hydrogen-water-intervention-on-acute-oral-inflammation-oral-microbiota-and-pain-following-free-flap-reconstruction-in-patients-with-oral-cancer-100616510","NCT07306546","Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer","Inclusion Criteria:\n\n* Diagnosed with oral cancer and receiving microsurgical free flap reconstruction.\n* Age 18 years or older.\n* Conscious and able to follow study instructions.\n* Able to communicate without difficulty in Mandarin, Taiwanese, or through written communication.\n\nExclusion Criteria:\n\n* Abnormal salivary gland function or severe xerostomia.\n* Recent use of antibacterial mouthwash or antibiotic therapy that may affect oral microbiota.\n* Presence of severe bacterial or viral oral infections, or significant periodontal disease.",{"count":85,"type":21},36,[87],"NA","This study employs a Randomized Controlled Trial (RCT) design. Patients diagnosed with oral cancer by the attending physician and who meet the inclusion criteria will be admitted to the study after receiving a full explanation of the study objectives, intervention methods, potential risks, and participant rights from the research team upon their stable transfer to the plastic surgery ward post-operation. Written consent will be obtained from the patient and\u002For their legally authorized representative after adequate informed consent has been provided, before they are enrolled in the study.",[27,90,91,92,93],"Postoperative Pain","Postoperative Oral Mucositis","Free Flap Reconstruction","Oral Cancer",[95,96,97,98,99],"Hydrogen water","Oral cancer","Free flap reconstruction","Pain assessment","Salivary Biomarkers","2025-12-25",{"date":102,"type":36},"2025-12-29",{"date":104,"type":21},"2026-01",{"date":106,"type":21},"2027-10-31",{"name":108,"class":43},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100603541","phase-2-adebrelimab-combined-with-carboplatin-and-albumin-bound-taxanol-in-the-treatment-of-resectable-locally-advanced-oral-squamous-cell-carcinoma-cardiac-randomized-phase-ii-exploratory-study-100603541","NCT07137858","Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study","Inclusion Criteria:\n\n1. Age between 18 and 75 years old;\n2. According to the 8th edition guidelines of the American Joint Committee on Cancer (AJCC), patients with pathologically confirmed head and neck squamous cell carcinoma (oral cavity including cheek, tongue, gum, floor of mouth, palate, maxillary sinus), and having stage III-IVB tumors other than oropharyngeal cancer;\n3. Before enrollment, the resectable tumors were evaluated by head and neck surgeons, and clinical evidence of distant metastasis was excluded;\n4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one measurable tumor lesion was present;\n5. The performance status of the Eastern Cooperative Oncology Group (ECOG) was 0-1;\n6. Blood routine: White blood cell count (WBC) ≥ 3.0×109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet (PLT) ≥ 100×109\u002FL; Hemoglobin level (HGB) ≥ 9.0 g\u002FdL (without corresponding supportive treatments such as blood transfusion and increase in white blood cells within 7 days);\n7. Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); Albumin (ALB) ≥ 30 g\u002FL;\n8. Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin (using the Cockcroft\u002FGault formula); Urinary protein (UPRO) \\\u003C (++), or 24-hour urine protein quantity \\\u003C 1.0 gram;\n9. HPV status of oropharyngeal cancer was determined by p16 IHC. If more than 70% of tumor cells showed strong diffuse nuclear and cytoplasmic staining, the sample was considered p16 positive;\n10. Within the past 30 days, no other clinical trial projects were participated in;\n11. Patients who voluntarily participated in this project and signed the informed consent form.\n\nExclusion Criteria:\n\n1. The patient's blood indicators were abnormal, and their liver and kidney functions were also abnormal. After a multidisciplinary consultation, it was determined that they could not tolerate the process of this clinical study.\n2. The patient had previously suffered from tumors in other parts of the body, or had undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy in the past.\n3. Due to personal, social, or economic reasons, they were unable to complete the entire clinical study process.\n4. The patient had previously suffered from severe systemic diseases that could not be cured or controlled by medication.",{"count":116,"type":21},70,[24],"Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.",[27,120],"Neoadjuvant Chemoimmunotherapy","2025-08-15",{"date":123,"type":36},"2025-08-22",{"date":121,"type":21},{"date":126,"type":21},"2027-12-31",{"name":128,"class":43},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":139,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":154,"locationsCount":44},"100603241","a-bidirectional-observational-clinical-study-of-naic-in-the-treatment-of-tumor-regression-patterns-in-la-oscc-and-la-opscc-100603241","NCT07133958","A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC","A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy","Inclusion Criteria:\n\n1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria\n2. Their age ranged from 18 to 80 years\n3. There was no history of other malignant tumors or treatment\n4. Adequate blood function: white blood cell count (WBC) ≥3.5×10\\^9\u002FL, platelet count (PLT) ≥75×10\\^9\u002FL; Hemoglobin concentration (HGB) ≥90g\u002FL\n5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal\n6. \"Adequate renal function: urinary white blood cells \\\u003C 10, red blood cells \\\u003C 10, cast count \\\u003C 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal.\n7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment\n8. PS score ≤2\n\nExclusion Criteria:\n\n1. Presence of distant metastasis\n2. Women who are pregnant or lactating\n3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons\n4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)\n5. Accompanied by severe uncontrolled infection or medical illness\n6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment\n7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction\n8. Long-term use of immunosuppressive agents after organ transplantation\n9. Patients with a history of other malignant tumors before enrollment","80 Years",{"count":138,"type":21},35,"2 Years","OBSERVATIONAL","A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin\u002Fcarboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.",[27,143],"Oropharyngeal Squamous Cell Carcinoma (SCC)",[145,146,147],"Oral squamous cell carcinoma","Oropharyngeal squamous cell carcinoma","neoadjuvant immunochemotherapy","2025-08-14",{"date":150,"type":36},"2025-08-21",{"date":152,"type":36},"2023-07-11",{"date":126,"type":21},{"name":155,"class":43},"Zhujiang Hospital",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":44},"100599047","phase-2-neoadjuvant-and-adjuvant-sintilimab-plus-cetuximab-in-locally-advanced-oral-and-oropharyngeal-squamous-cell-carcinoma-100599047","NCT07079410","Neoadjuvant and Adjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma","A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma","OSCC","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed oral\u002Foropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) \\>1\n2. Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET\u002FCT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+\u002F- chemotherapy.\n3. Age ranges from 18 to 75 years old\n4. ECOG performance status 0 or 1.\n5. Expected survival ≥ 3 months.\n6. Participants must have not received treatment for before.\n7. There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.\n8. The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and\u002For confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.\n9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 \\^ 9\u002FL; Neutrophil count (NEUT) ≥ 1.5 × 10 \\^ 9\u002FL, platelet count (PLT) ≥ 100 × 10 \\^ 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).\n11. The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Squamous cell carcinoma with primary site of nasopharynx or skin.\n2. Diagnosed with malignant diseases other than head and neck squamous cell carcinoma within 3 years before the first administration (excluding Radical treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curative excised carcinoma in situ)\n3. Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).\n4. Has received live or attenuated vaccines within 30 days prior to the first dose of Sintilimab, inactivated vaccines are allowed.\n5. Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg\u002Fday of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.\n6. Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia\u002Finterstitial lung disease requiring steroid treatment, or current pneumonia\u002Finterstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen \\[HBsAg\\]) or known history of active hepatitis C virus (defined as detection of HCV RNA \\[qualitative\\]) infection; Has a known history of human immunodeficiency virus (HIV) infection.\n7. Has received allogeneic tissue\u002Fsolid organ transplantation.\n8. Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia.\n9. Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。\n10. Has severe clinical infection (\\>NCI-CTCAE 5.0 Level 2 infection);\n11. Has uncontrollable hypertension (systolic blood pressure\\>150mmHg and\u002For diastolic blood pressure\\>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.\n12. Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Has participated in other clinical studies within 30 days prior to enrollment.\n15. Other situations that researchers consider unsuitable for participation in the study.",{"count":165,"type":21},50,[24],"The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral\u002Fpharyngeal squamous cell carcinoma.",[27,169,170],"Oropharyngeal Squamous Cell Carcinoma","Resectable Oral and Oropharyngeal Squamous Cell Carcinoma",[172],"locally advanced OSCC","2025-07-22",{"date":175,"type":36},"2025-07-23",{"date":177,"type":21},"2025-07",{"date":179,"type":21},"2029-10",{"name":181,"class":43},"Shanghai Zhongshan Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":201,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":219},"100498763","sentinel-node-biopsy-versus-limited-elective-neck-dissection-in-early-cancers-of-oral-cavity-node-negative-100498763","NCT05774483","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial","SECOND N0","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa\n3. T1 and T2 lesions as per AJCC TNM 8 edition\n4. Clinicoradiologically node negative\n5. Amenable to per oral excision\n6. Treatment naïve\n7. No other site of malignancy\n\nExclusion Criteria:\n\n1. Previous surgery in the head and neck region,\n2. Upper alveolar or palatal lesions\n3. Large heterogeneous leukoplakia or other premalignant lesions\n4. Previous malignancy in the head and neck region\n5. Patients requiring the free flap reconstruction",{"count":191,"type":21},508,[87],"The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.\n\nThe main questions it aims to answer are:\n\n* Survival outcomes\n* Morbidity outcomes\n* Cost-effectiveness\n\nParticipants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.",[195,196,27,197,198,199,200],"Mouth Neoplasms","Oral Cancers","Oral Squamous Cell Carcinomas","Sentinel Lymph Node Biopsy","Sentinel Lymph Node Biopsy (SLNB)","Sentinel Lymph Node",[202,203,204,205,206,207,208],"mouth neoplasms","neck dissection","sentinel lymph node biopsy","survival","morbidity","oral cancers","oral squamous cell carcinoma","2025-07-14",{"date":211,"type":36},"2025-07-17",{"date":213,"type":36},"2025-04-16",{"date":215,"type":21},"2034-04",{"name":217,"class":218},"Tata Memorial Hospital","OTHER_GOV",3,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100595166","early-phase-1-a-prospective-single-arm-studyncldr-100595166","NCT07028918","A Prospective Single-Arm Study（NCLDR）","Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study","NCLDR","【Inclusion Criteria】:\n\n1. Age: 18 to 70 years old (inclusive) at the time of enrollment, based on the Gregorian calendar birth date. Age calculation is based on the date of signing the informed consent form. Includes both males and females.\n2. ECOG Performance Status: 0-1.\n3. Life Expectancy: ≥ 6 months.\n4. Diagnosis: Histologically confirmed oral squamous cell carcinoma.\n5. Clinical Stage: Stage III, IVA, or IVB according to AJCC clinical staging.\n6. Absence of Distant Metastasis: No evidence of distant metastasis confirmed by auxiliary examinations.\n7. Prior Anti-tumor Therapy: No previous surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments.\n8. Measurable Lesion: At least one measurable target lesion according to RECIST 1.1 criteria, confirmed by imaging during the screening period.\n9. Adequate Organ Function: Meeting the following criteria:\n\n   * Hematology: White blood cell count (WBC) ≥ 4.0 x 10⁹\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Platelets (PLT) ≥ 100 x 10⁹\u002FL.\n   * Liver Function: ALT and AST \\\u003C 3 x Upper Limit of Normal (ULN); Total bilirubin \\\u003C 1.5 x ULN; Child-Pugh class A or B; Normal liver tissue volume ≥ 700 cm³.\n   * Renal Function: Serum creatinine \\\u003C 1.5 x ULN.\n   * Coagulation: International Normalized Ratio (INR) and Activated Partial ·Thromboplastin Time (APTT) ≤ 1.5 x ULN.\n   * Serum Albumin: ≥ 28 g\u002FL.\n   * Urinalysis: Urine protein \\\u003C 2+ (If baseline urine protein ≥ 2+, a 24-hour urine protein quantification must be performed within 7 days; enrollment requires quantification \\\u003C 1g).\n   * Electrocardiogram (ECG): No significant abnormalities.\n   * Cardiac Function: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n10. Contraception: Women of childbearing potential must have reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. They must be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug. Men must agree to use adequate contraception or be surgically sterilized during the trial and for 8 weeks after the last dose of the study drug.\n11. Informed Consent: Ability to understand and voluntarily sign the informed consent form (signed by a legal representative if the participant loses capacity), with expected good compliance.\n\n【Exclusion Criteria】:\n\n1. Unsuitable for Treatment: Unsuitable for receiving the protocol-specified low-dose radiotherapy, immunotherapy, and chemotherapy.\n2. Prior Anti-tumor Therapy: Previous treatment with anti-tumor therapy, including investigational drugs, chemotherapy, radiotherapy, or prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies\u002Fdrugs, or any other antibody\u002Fdrug specifically targeting T-cell co-stimulatory checkpoint pathways.\n3. Active Infection: Severe active infection requiring systemic therapy.\n4. Cardiovascular\u002FCerebrovascular Events: History within 6 months prior to study treatment of: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.\n5. Bleeding Tendency\u002FDisorder: Definite bleeding tendency or clinically significant bleeding symptoms within 28 days, including but not limited to gastrointestinal bleeding, epistaxis (excluding minor nosebleeds and blood-tinged sputum), or ongoing hemorrhagic or coagulopathic disease.\n6. Systemic Corticosteroids: Requirement for systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent dose) or replacement therapy (\\>10 mg\u002Fday prednisone equivalent) within 14 days prior to study treatment.\n7. Recent Procedures: Live vaccination within 4 weeks prior to study treatment or planned during the study period. Major surgery within 4 weeks prior to study treatment.\n8. Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n9. Infectious Disease:\n\n   * Known immunodeficiency.\n   * Known history of Human Immunodeficiency Virus (HIV) or Acquired --·Immunodeficiency Syndrome (AIDS)-defining illness.\n   * Hepatitis B Virus (HBV) infection (HBsAg positive) or Hepatitis C Virus (HCV) ·infection (HCV RNA positive if anti-HCV antibody screening is positive).\n   * Known active history of Tuberculosis (TB).\n10. Other Exclusionary Conditions: Any other factor identified by the investigator that may lead to premature termination of the study, such as severe laboratory abnormalities, or concomitant familial or social factors that could compromise participant safety or affect data\u002Fsample collection.","70 Years",{"count":138,"type":21},[231],"EARLY_PHASE1","To investigate the safety and efficacy of low-dose radiotherapy combined with chemotherapy and immunotherapy as neoadjuvant therapy for locally advanced oral squamous cell carcinoma (OSCC), and to explore whether low-dose radiotherapy can induce cross-presentation of tumor-specific antigens, enhance lymphocyte infiltration into the tumor microenvironment, and thereby amplify tumor-specific immune responses, ultimately improving the therapeutic outcomes of neoadjuvant chemoimmunotherapy.",[27],[235],"Phase III, IVA, and IVB","2025-06-11",{"date":238,"type":36},"2025-06-19",{"date":240,"type":21},"2025-08-30",{"date":242,"type":21},"2027-08-30",{"name":244,"class":43},"Qilu Hospital of Shandong University",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":44},"100582315","phase-2-chemoimmunotherapy-with-or-without-sbrt-before-surgery-for-locally-advanced-oral-and-oropharyngeal-cancer-100582315","NCT06861712","Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer","Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial","Inclusion Criteria:\n\n1. Oral\u002Foropharyngeal squamous cell carcinoma confirmed by histology and\u002For cytology.\n2. Clinical stage: resectable oral\u002Foropharyngeal squamous cell carcinoma stage III-IVa (AJCC 8th edition)\n3. Age: 18-65 years old.\n4. According to the Eastern Cooperative Oncology Group (ECOG) criteria (performance status score of 0 or 1).\n5. Good organ function:\n\n   A. Hematology: WBC ≥ 4000\u002FμL, neutrophil ≥ 2.000\u002FμL, hemoglobin ≥ 9g\u002FdL, platelet ≥ 100000\u002FμL; B. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times, and alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3g\u002FdL; C. International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; D. Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60mL\u002Fmin according to the Cockcroft-Gault formula.\n6. Expected survival ≥ 3 months.\n7. The patient has signed an informed consent form and is willing and able to comply with the study visits, treatment plans, laboratory tests and other study procedures.\n8. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose (including chemotherapy drugs and Teplizumab).\n9. If the female partner of the male subject is still of childbearing potential, the male subject must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors.\n2. Patients with known or suspected autoimmune diseases, including dementia and epilepsy.\n3. Patients with severe mental illness.\n4. Patients with necrotic lesions and who are assessed by the researchers to be at risk of major bleeding.\n5. Patients with severe heart disease, pulmonary dysfunction, heart function and pulmonary function below grade 3 (including grade 3).\n6. Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment.\n7. Patients who have received systemic or local glucocorticoid treatment within 4 weeks before enrollment.\n8. Patients with complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects.\n9. Patients with active pulmonary tuberculosis (TB) who are currently receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.\n10. Previous use of anti-toripalimab, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway).\n11. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood and no need for any intervention as adults can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included).\n12. HIV positive.\n13. HBsAg positive and HBVDNA copy number positive (quantitative detection ≥1000cps\u002Fml); positive blood screening for chronic hepatitis C (HCV antibody positive).\n14. Any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) received within 4 weeks before enrollment.\n15. Women of childbearing age with positive pregnancy test and breastfeeding women.","65 Years",{"count":165,"type":21},[24],"In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.",[27,143,257],"Stereotactic Body Radiation Therapy (SBRT)",[27,143,257,259,260],"Toripalimab","Phase II Clinical Trial","2025-04-22",{"date":263,"type":36},"2025-04-25",{"date":265,"type":21},"2025-05-06",{"date":267,"type":21},"2026-12-31",{"name":269,"class":43},"Sun Yat-sen University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":284,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":44},"100571919","quantitative-margin-assessment-using-high-resolution-positron-emission-tomography---computed-tomograhy-100571919","NCT06726512","Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy","qMAP","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.\n* Patient is indicated to undergo curative surgery of the primary tumor.\n* Patient is estimated compliant for study participation by the investigator.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;\n* Patient has previously received radiotherapy of the primary tumor region;\n* Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;\n* A blood glucose level over 200 mg\u002FdL on the day of surgery.\n* Pregnancy or lactation.",{"count":278,"type":21},30,[87],"The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.",[93,282,283,27],"Osteosarcoma","Soft Tissue Sarcoma",[285,286,287],"margin assessment","image-guided surgery","PET-CT","2024-12-09",{"date":290,"type":36},"2024-12-10",{"date":292,"type":21},"2025-01",{"date":294,"type":21},"2026-04",{"name":296,"class":43},"University Medical Center Groningen",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":162,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":44},"100572080","phase-2-preoperative-tislelizumab--cetuximab---chemotherapy-followed-by-salvage-surgery-and-adjuvant-tislelizumab--cetuximab-for-resectable-locally-recurrent-oral-and-oropharyngeal-squamous-cell-carcinoma-100572080","NCT06728618","Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Tislelizumab -Cetuximab - TP(cisplatin and Albumin-paclitaxel) Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed locoregionally recurrent oral\u002Foropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils).\n2. Participants must have documented time of ≥ 16 weeks from completion of prior curative intent treatment for OSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence.\n3. Age ranges from 18 to 75 years old\n4. ECOG performance status 0 or 1.\n5. Expected survival ≥ 12 weeks.\n6. The participants are clinically evaluated to be eligible for salvage surgery and must be intended to undergo salvage surgery.\n7. There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.\n8. The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and\u002For confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.\n9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 \\^ 9\u002FL; Neutrophil count (NEUT) ≥ 1.5 × 10 \\^ 9\u002FL, platelet count (PLT) ≥ 100 × 10 \\^ 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).\n11. The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Has known distant metastasis of the disease.\n2. Has received chemotherapy or radiotherapy for curative treatment of oral\u002Foropharyngeal squamous cell carcinoma within the 16 weeks prior to enrollment in the study.\n3. Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).\n4. Has received live or attenuated vaccines within 30 days prior to the first dose of Tislelizumab, inactivated vaccines are allowed.\n5. Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg\u002Fday of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.\n6. Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia\u002Finterstitial lung disease requiring steroid treatment, or current pneumonia\u002Finterstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen \\[HBsAg\\]) or known history of active hepatitis C virus (defined as detection of HCV RNA \\[qualitative\\]) infection; Has a known history of human immunodeficiency virus (HIV) infection.\n7. Has received allogeneic tissue\u002Fsolid organ transplantation.\n8. Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia.\n9. Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。\n10. Has severe clinical infection (\\>NCI-CTCAE 5.0 Level 2 infection);\n11. Has uncontrollable hypertension (systolic blood pressure\\>150mmHg and\u002For diastolic blood pressure\\>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.\n12. Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Has participated in other clinical studies within 30 days prior to enrollment.\n15. Other situations that researchers consider unsuitable for participation in the study.",{"count":305,"type":21},28,[24],"The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral\u002Fpharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.",[27,143,170,309],"Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","2024-12-08",{"date":312,"type":36},"2024-12-11",{"date":314,"type":21},"2024-12",{"date":316,"type":21},"2028-03",{"name":181,"class":43},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":44},"100562179","clinical-outcomes-of-thoracodorsal-artery-flap-in-oral-and-maxillofacial-reconstruction-100562179","NCT06599801","Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction","The Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Defect Reconstruction: a Retrospective Study","Inclusion Criteria:\n\n1. Patients with oral squamous cell carcinoma who have completed comprehensive imaging examinations before surgery.\n2. Preoperative pathological biopsy confirmed as oral squamous cell carcinoma.\n3. Patients with oral squamous cell carcinoma who have completed comprehensive laboratory tests before surgery.\n4. Patients with oral squamous cell carcinoma who underwent tumor resection and flap reconstruction at our hospital.\n5. Postoperative pathological diagnosis confirmed as oral squamous cell carcinoma.\n6. Patients with oral squamous cell carcinoma who attend follow-up visits at 1, 3, 6, and 12 months post-surgery, completing all clinical examinations and questionnaires.\n\nExclusion Criteria:\n\n1. Patients with oral squamous cell carcinoma who lack imaging data or have artifacts affecting imaging results.\n2. Patients with oral squamous cell carcinoma who have incomplete laboratory test results from our hospital.\n3. Patients with oral squamous cell carcinoma with postoperative pathology that remains unclear or cannot be confirmed as oral squamous cell carcinoma.\n4. Patients with oral squamous cell carcinoma who are unable to attend follow-up visits at 1, 3, 6, and 12 months.\n5. Patients who do not complete the questionnaires as required during follow-up visits.",{"count":326,"type":21},217,"The goal of this study is to retrospectively compare different types of free flaps to determine the most suitable free flap for functional reconstruction in oral squamous cell carcinoma patients following tumor resection. The main questions it aims to answer are:\n\nDo the clinical characteristics of the thoracodorsal artery perforator flap differ from those of other types of flaps? Does the thoracodorsal artery perforator flap result in better clinical outcomes compared to other types of flaps? After reconstruction with the thoracodorsal artery perforator flap, do patients have better quality of life, speech function and scar healing compared to other types of flaps? Investigators will retrospectively compare the thoracodorsal artery perforator flap with other types of flaps (such as the anterolateral thigh flap, forearm flap, latissimus dorsi flap and fibula flap) to explore the most suitable free flap for facial defect reconstruction in oral squamous cell carcinoma patients.\n\nParticipants are oral squamous cell carcinoma patients who previously underwent facial defect reconstruction with different types of flaps. Participants have completed relevant questionnaires at 1, 3, 6 and 12 months post-surgery. The data will be scored and assessed by the investigators.",[27],[61,330,331,332],"thoracodorsal artery perforator flap","quality of life","free flap","2024-09-13",{"date":335,"type":36},"2024-09-19",{"date":337,"type":21},"2024-09-30",{"date":339,"type":21},"2025-09-30",{"name":128,"class":43}]