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 (CDK4/6 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/B deletion, CDK4/6 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.
Patients aged ≥18 years;
Males or females who are not pregnant or breastfeeding;
ECOG performance status of 0-1, with no deterioration within the past 7 days;
Patients with histologically confirmed, locally advanced, resectable head and neck squamous cell carcinoma;
Previous receipt of any antitumor therapy for head and neck squamous cell carcinoma;
Administration of a live vaccine within 4 weeks prior to enrollment or likely to occur during the study period;
Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment;
Previous allogeneic bone marrow or organ transplantation;
Single group
Adebrelimab Injection
DrugDose: 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.
Dalpiciclib Isethionate
Drug100mg/125mg, 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.
Cisplatin
DrugDose: 75 mg/m² Route: Intravenous drip Schedule: Day 1 of each 21-day cycle, every 3 weeks for 2 cycles total Description: Dose reduced to 40mg/m² if creatinine clearance 40-50 mL/min; discontinue cisplatin if CrCl \<40 mL/min; 20% dose reduction for grade 3-4 related toxicities.
Radical Surgical Resection
Procedure/SurgeryTiming: 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.
Pathological Complete Response (pCR) Rate
Percentage of subjects achieving pathological complete response in primary tumor and regional lymph nodes after neoadjuvant therapy (no viable tumor cells in surgical specimen)
Major Pathological Response (MPR) Rate
Proportion of patients with ≤10% residual viable tumor cells in surgical specimen
Objective Response Rate (ORR)
Percentage of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST 1.1 on post-neoadjuvant contrast-enhanced CT
Disease Control Rate (DCR)
Proportion of patients with CR, PR or Stable Disease (SD) per RECIST 1.1
Progression-Free Survival (PFS)
Time from first study drug administration to first documentation of disease progression (local/regional/distant) or death from any cause
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