[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qunxing Li,MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100621514","phase-3-sintilimab-plus-chemotherapy-as-neoadjuvant-and-adjuvant-treatment-for-locally-advanced-oral-squamous-cell-carcinoma-100621514",false,"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.","ALL","18 Years","75 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Locally Advanced Oral Squamous Cell Carcinoma","Oral Squamous Cell Carcinoma (OSCC)",[30,31,32,33,34,35,36],"Oral Squamous Cell Carcinoma","Locally Advanced","Sintilimab","Perioperative Immunotherapy","Neoadjuvant Therapy","Adjuvant Therapy","Randomized Phase III Trial","RECRUITING","2026-01-19",{"date":40,"type":41},"2026-01-28","ACTUAL",{"date":43,"type":21},"2026-01-01",{"date":45,"type":21},"2033-12-31",{"name":47,"class":48},"Qunxing Li,MD","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100621381","comparison-of-efficacy-between-de-escalated-surgery-and-standard-surgery-after-neoadjuvant-immunotherapy-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100621381","NCT07369882","Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Comparison of Efficacy Between De-escalated Surgery and Standard Surgery After Neoadjuvant Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Randomized, Single-center Exploratory Clinical Study","Inclusion Criteria:\n\n* Patients diagnosed with stage III-IVa head and neck squamous cell carcinoma (HNSCC) according to the AJCC 8th edition TNM staging system, who have achieved a partial response (PR) or complete response (CR) after receiving neoadjuvant immunochemotherapy consisting of a PD-1 inhibitor in combination with nab-paclitaxel and carboplatin\u002Fcisplatin.\n* No prior history of other malignant tumors.\n* Aged between 18 and 75 years.\n* Normal baseline (preoperative) clinical and laboratory findings:\n* 1.Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without the use of granulocyte colony-stimulating factor (G-CSF) within the previous 14 days\n* 2.Platelet count ≥ 100 × 10⁹\u002FL without blood transfusion within the previous 14 days\n* 3.Hemoglobin \\> 9 g\u002FdL without blood transfusion or erythropoietin use within the previous 14 days\n* 4.Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n* 5\\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* 6\\. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin\n* 7\\. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN\n* 8\\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with TSH outside the normal range may be included if total T3 (or FT3) and FT4 are within normal limits\n* 9\\. Normal myocardial enzyme profile (minor laboratory abnormalities judged by the investigator to be clinically insignificant are acceptable)\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1). If the urine test is indeterminate, a serum test must be performed. Non-childbearing females are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy.\n* All subjects (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate \\\u003C1%) during treatment and for at least 120 days after the last dose of study drug, or 180 days after the last dose of chemotherapy.\n* Adverse events related to neoadjuvant therapy (e.g., bone marrow suppression, thyroiditis, hypothyroidism, hepatitis, nephritis, myocarditis, myositis, etc.) must have been adequately controlled and resolved to grade 0-2 before surgery. Patients assessed by anesthesiology as fit for general anesthesia may be included.\n* Patients with pre-existing comorbidities prior to neoadjuvant therapy may also be enrolled if evaluated by anesthesiology and deemed able to tolerate general anesthesia.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of another malignant tumor, or the primary lesion at the time of neoadjuvant therapy was not oral cancer.\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to treatment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n* History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1\u002F2 antibody).\n* Untreated active hepatitis B infection, defined as HBsAg positivity with HBV-DNA levels exceeding the upper limit of normal (ULN) at the study site laboratory. Subjects meeting the following criteria may be enrolled:\n* a. HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) prior to first dosing, provided antiviral therapy is administered throughout the study period to prevent viral reactivation\n* b. Subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV-DNA(-) do not require prophylactic antiviral therapy but must undergo close monitoring for viral reactivation.\n* Active hepatitis C virus (HCV) infection, defined as positive HCV antibody with detectable HCV-RNA above the lower limit of detection.\n* Pregnant or lactating women.\n* Presence of severe or uncontrolled systemic diseases, including but not limited to:\n* 1\\. Cardiac disorders: severe arrhythmias (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or persistent atrial fibrillation), unstable angina, or congestive heart failure (NYHA class ≥ II)\n* 2\\. Vascular diseases: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months prior to enrollment\n* 3\\. Poorly controlled hypertension: systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg\n* 4\\. Pulmonary diseases: noninfectious pneumonitis requiring corticosteroid treatment within 1 year before first dosing, or active interstitial lung disease\n* 5\\. Infectious diseases: active infections requiring systemic therapy, or severe uncontrolled infections\n* 6\\. Active pulmonary tuberculosis\n* 7\\. Gastrointestinal diseases: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction\n* 8\\. Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis\n* 9\\. Uncontrolled diabetes mellitus: fasting blood glucose (FBG) \\> 10 mmol\u002FL\n* 10\\. Renal dysfunction: urine protein ≥ ++ on routine urinalysis and 24-hour urinary protein \\> 1.0 g\n* 11\\. Psychiatric disorders: severe mental illness that may affect treatment compliance.",{"count":58,"type":21},60,[60],"NA","This is a single-center, open-label, randomized, controlled, exploratory clinical trial designed to evaluate the efficacy and safety of de-escalated surgery compared with standard surgery in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who achieved a partial response (PR) or complete response (CR) after neoadjuvant immunochemotherapy. Eligible patients will be randomly assigned in a 1:1 ratio to either the de-escalated surgery group (experimental) or the standard surgery group (control). The de-escalated surgery group will undergo limited tumor resection and selective neck dissection based on clinical and imaging response, while preserving important anatomical structures and functions when feasible. The control group will receive standard surgical treatment following NCCN guidelines. All patients will be evaluated using RECIST 1.1 criteria for radiological response and will undergo enhanced CT or MRI at baseline, before the second cycle of neoadjuvant therapy, within one week before surgery, 30 days after surgery, and every 3 months thereafter until 2 years post-surgery, disease recurrence, death, or study completion. The study aims to assess whether de-escalated surgery can achieve similar oncologic outcomes while improving postoperative function and quality of life. The primary endpoints are disease-free survival (DFS), health-related quality of life (HRQoL), and 3- and 5-year overall survival rates (OS rate). A total of 60 patients will be enrolled over a 3-year period, with 30 in each group.",[63],"Locally Advanced Head and Neck Squamous Cell Carcinoma",[65,66,67,68],"head and neck squamous cell carcinoma","locally advanced","De-escalated Surgery","Neoadjuvant","2026-01-18",{"date":71,"type":41},"2026-01-27",{"date":73,"type":21},"2026-01-12",{"date":75,"type":21},"2030-01-31",{"name":47,"class":48},""]