[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-oral-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-oral-squamous-cell-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,83],{"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":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628089","impact-of-postoperative-radiotherapy-versus-pd-1-inhibitor-maintenance-on-survival-in-resectable-locally-advanced-oral-and-oropharyngeal-squamous-cell-carcinoma-100628089",false,"NCT07457099","Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma","Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Patients With Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy and Radical Surgery: A Single-Center Ambispective Cohort Study","Inclusion Criteria:\n\n1. Age 18-80 years, any gender.\n2. Expected survival ≥ 6 months.\n3. Adequate major organ function; ECOG performance status 0-1.\n4. Treatment-naïve patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC), in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) staging system (2017) and the 2020 Chinese Stomatological Association (CSA) guidelines for pathological diagnosis of oral and oropharyngeal cancers, with clinical stages: cT3N0M0, cT1-3N1M0, cT4aN0-2M0, cT1-4aN3M0, or cT4bN0-3M0.\n5. No evidence of distant metastasis based on auxiliary examinations.\n6. No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies.\n7. Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection.\n8. Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after.\n9. Signed informed consent (if the participant lacks capacity, by a legally authorized representative), voluntarily participates in the study, and demonstrates good compliance.\n\nExclusion Criteria:\n\n1. History of radiotherapy to the head and neck region.\n2. Severe bone marrow suppression, hepatic or renal failure, or uncontrolled severe infections, cardiovascular diseases, or other conditions that may preclude tolerance of treatment.\n3. Active autoimmune diseases, history of organ transplantation requiring long-term immunosuppressive therapy, or severe immunodeficiency that may result in serious immune-related adverse events.\n4. Active infections requiring systemic therapy.\n5. Cardiovascular\u002Fcerebrovascular events within 6 months prior to study treatment, including myocardial infarction, severe\u002Funstable angina, coronary or peripheral artery bypass surgery, symptomatic heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.\n6. Bleeding tendency\u002Fdisorders: clinically significant bleeding or clear bleeding tendency within the past 28 days, including but not limited to gastrointestinal bleeding, epistaxis (excluding mild nosebleeds or blood-streaked sputum), or persistent bleeding\u002Fclotting disorders.\n7. History of substance abuse, alcoholism, or drug abuse.\n8. Pregnant or breastfeeding women.\n9. Participation in other interventional clinical trials simultaneously.","ALL","18 Years","80 Years",{"count":20,"type":21},85,"ESTIMATED","OBSERVATIONAL","Neoadjuvant immunochemotherapy (NAIC) has demonstrated promising pathological and survival outcomes in patients with resectable locally advanced oral and oropharyngeal squamous cell carcinoma (LA-OSCC\u002FOPSCC). However, the optimal postoperative management strategy following NAIC and radical surgery remains undefined, particularly regarding the necessity of postoperative radiotherapy and the potential role of PD-1 inhibitor maintenance therapy.\n\nThis single-center, ambispective cohort study aims to compare event-free survival, pathological response, survival outcomes, failure patterns, treatment-related toxicities, and functional outcomes among three postoperative strategies: postoperative radiotherapy, postoperative PD-1 inhibitor maintenance, and observation alone. The study seeks to provide real-world evidence to support risk-adapted, individualized postoperative decision-making after NAIC",[25,26],"Locally Advanced Oral Squamous Cell Carcinoma","Locally Advanced Oropharyngeal Squamous Cell Carcinoma",[28,29,30,31,32,33,34,35],"Neoadjuvant immunochemotherapy","oral cancer","oropharyngeal cancer","PD-1 inhibitor","postoperative radiotherapy","event-free survival","pathological response","real-world study","NOT_YET_RECRUITING","2026-03-03",{"date":39,"type":40},"2026-03-09","ACTUAL",{"date":42,"type":21},"2026-04-01",{"date":44,"type":21},"2028-06-30",{"name":46,"class":47},"Zhujiang Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":48},"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":58,"type":21},104,"INTERVENTIONAL",[61],"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.",[25,64],"Oral Squamous Cell Carcinoma (OSCC)",[66,67,68,69,70,71,72],"Oral Squamous Cell Carcinoma","Locally Advanced","Sintilimab","Perioperative Immunotherapy","Neoadjuvant Therapy","Adjuvant Therapy","Randomized Phase III Trial","RECRUITING","2026-01-19",{"date":76,"type":40},"2026-01-28",{"date":78,"type":21},"2026-01-01",{"date":80,"type":21},"2033-12-31",{"name":82,"class":47},"Qunxing Li,MD",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100601512","prospective-cohort-study-on-oral-microbiome-changes-in-patients-with-locally-advanced-oral-squamous-cell-carcinoma-following-neoadjuvant-chemoimmunotherapy-100601512","NCT07111455","Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy","Inclusion Criteria:\n\n1. Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria.\n2. Their age ranged from 18 to 80 years;regardless of gender.\n3. Absence of prior head and neck radiation therapy or chemotherapy.\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) \\\u003C＝ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C＝2.5 times the upper limit of normal.\n6. Adequate renal function：estimated glomerular filtration rate (eGFR) greater than 45 mL\u002Fmin per 1.73 m².\n7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI.\n8. PS score \\\u003C＝2.\n9. Signed informed consent form and voluntarily agreeing to participate in this study.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation (for female participants).\n2. Patients with a history of epilepsy or psychiatric disorders that were not well-controlled.\n3. Patients with severe allergic diathesis or suspected or confirmed alcohol or drug addiction.\n4. Patients who had taken antibiotics within 7 days before enrollment.",{"count":90,"type":21},32,"Investigating the Relationship Between Oral Microbiome Alterations and Tumor Markers in Locally Advanced Oral Squamous Cell Carcinoma (LA-OSCC) After Neoadjuvant Chemoimmunotherapy: Implications for Therapeutic Efficacy, Chemoresistance, and Prognostic Assessment",[25],[94,95],"Oral Microbiome","Neoadjuvant Chemoimmunotherapy","2025-09-21",{"date":98,"type":40},"2025-09-23",{"date":100,"type":40},"2025-07-22",{"date":102,"type":21},"2027-07-30",{"name":46,"class":47}]