[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652804":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":36,"locations":11,"responsibleParty":42,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":11},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Triplet Combination Therapy Arm","EXPERIMENTAL",null,[13,14,15,16],"Drug: Adebrelimab Injection","Drug: Dalpiciclib Isethionate","Drug: Cisplatin","Procedure: Radical Surgical Resection",[18,23,27,31],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Adebrelimab Injection","Dose: 1200 mg Route: Intravenous Infusion Schedule: Day 1 of each 21-day cycle, every 3 weeks for 2 cycles total Description: Intravenous infusion over 30 minutes (20-60 min window), no dose reduction allowed; suspend or permanently discontinue per immune-related adverse events.",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"Dalpiciclib Isethionate","100mg\u002F125mg, Schedule: Days 1-21 of every 28-day cycle, continuous oral administration Description: Dose modification per CTCAE v5.0 toxicity grading; permanent discontinuation for ≥2 grade interstitial lung disease, grade 4 hepatotoxicity.",[9],{"type":19,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Cisplatin","Dose: 75 mg\u002Fm² Route: Intravenous drip Schedule: Day 1 of each 21-day cycle, every 3 weeks for 2 cycles total Description: Dose reduced to 40mg\u002Fm² if creatinine clearance 40-50 mL\u002Fmin; discontinue cisplatin if CrCl \\\u003C40 mL\u002Fmin; 20% dose reduction for grade 3-4 related toxicities.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"PROCEDURE","Radical Surgical Resection","Timing: 4-6 weeks after completion of 2 neoadjuvant cycles Description: Curative surgical resection of primary tumor and regional lymph nodes per standard head and neck oncology guidelines.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Chunhua She Chunhua She","CONTACT","+86 18622963076","nansechunhua@163.com",{"type":43,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652804","phase-2-adebrelimab-combined-with-dalpiciclib-isethionate-plus-chemotherapy-for-neoadjuvant-treatment-of-locally-advanced-head-and-neck-squamous-cell-carcinoma-100652804",false,"NCT07778732","Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Open-Label, Phase II Clinical Trial of Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients aged ≥18 years;\n* Males or females who are not pregnant or breastfeeding;\n* ECOG performance status of 0-1, with no deterioration within the past 7 days;\n* Patients with histologically confirmed, locally advanced, resectable head and neck squamous cell carcinoma;\n* Patients who have not previously received any systemic treatment regimens for this cancer type;\n* Patients receiving neoadjuvant therapy must have evaluable lesions;\n* Adequate organ and bone marrow function, with laboratory test results meeting the following requirements:\n\n  1. HGB ≥ 90 g\u002FL;\n  2. NEUT ≥ 1.5 × 10⁹\u002FL;\n  3. PLT ≥ 80 × 10⁹\u002FL;\n  4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n  5. ALT and AST ≤ 2.5 × ULN; in cases of liver metastases, ALT and AST ≤ 5 × ULN;\n  6. Endogenous creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n  7. Urinary protein \\\u003C (++), or 24-hour urinary protein \\\u003C 1.0 g.\n* Normal coagulation function with no active bleeding\n\n  1. International Normalized Ratio (INR) ≤ 1.5;\n  2. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).\n* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug.\n* Expected survival ≥ 12 months.\n* Patients must voluntarily enroll in this study and sign an Informed Consent Form (ICF).\n* Patients are expected to demonstrate good compliance and be able to follow up on efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* Previous receipt of any antitumor therapy for head and neck squamous cell carcinoma;\n* Administration of a live vaccine within 4 weeks prior to enrollment or likely to occur during the study period;\n* Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment;\n* Previous allogeneic bone marrow or organ transplantation;\n* Uncontrolled hypertension prior to enrollment, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Any disease or condition prior to enrollment that affects drug absorption;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class \\>2 congestive heart failure; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) \\\u003C50%;\n* Active or uncontrolled severe infection (≥CTCAE v5.0 Grade 2 infection); 9. Known human immunodeficiency virus (HIV) infection. History of clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must be free of active HBV infection, i.e., HBV DNA positive (\\>1×10⁴ copies\u002FmL or \\>2,000 IU\u002FmL); known hepatitis C virus (HCV) infection with HCV RNA positive (\\>1×10³ copies\u002FmL) ;\n* Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities that, in the investigator's judgment, give reason to suspect that the patient has a condition or state that makes them unsuitable for the study drug (e.g., a history of epileptic seizures requiring treatment), or that will affect the interpretation of study results, or that places the patient at high risk;\n* Patients whom the investigator deems unsuitable for enrollment in this study.","ALL","18 Years",{"count":54,"type":55},32,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This single-center, open-label Phase II trial aims to evaluate the efficacy and safety of neoadjuvant combination therapy with Adebrelimab (anti-PD-L1), Dalpiciclib Isethionate (CDK4\u002F6 inhibitor), and cisplatin chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). A total of 32 eligible subjects will receive 2 cycles of triplet neoadjuvant treatment prior to radical surgery. The primary endpoint is the pathological complete response (pCR) rate following neoadjuvant therapy; secondary endpoints include major pathological response (MPR), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year overall survival (1y-OS), and treatment-related adverse events (TRAEs). The exploratory objectives analyze correlations between biomarkers (oral microbiome, CDKN2A\u002FB deletion, CDK4\u002F6 amplification, and PD-L1 expression) and therapeutic efficacy or prognosis. Subjects will receive long-term tumor and survival follow-up after surgery until disease progression, death, loss to follow-up, or the end of study.",[61],"HNSCC","NOT_YET_RECRUITING","2026-08-19",{"date":65,"type":66},"2026-08-21","ACTUAL",{"date":68,"type":55},"2026-09-01",{"date":70,"type":55},"2028-09-01",{"name":5,"class":6}]