locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
Conditions
Interventions
Experimental group:Chemotherapy + Immunotherapy + Surgery
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed HPV-negative head and neck squamous cell carcinoma (HNSCC), staged as T1–2N2–3M0 or T3–4aN0–3M0; 2.No prior systemic and/or local treatment for head and neck tumors; 3.Male or female, aged >=18 years and = 1.5 × 10^9/L without the use of granulocyte colony-stimulating factor within 14 days prior to assessment; 2. Platelet count >= 100 × 10^9/L without blood transfusion within 14 days prior to assessment. 3. Hemoglobin >= 9 g/dL (90 g/L) or >= 5.6 mmol/L without blood transfusion or use of erythropoietin-stimulating agents within 14 days prior to assessment. 4. Total bilirubin ULN with direct bilirubin = 60 mL/min. 7. Normal coagulation function: International normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; or, if on anticoagulation therapy, PT or partial thromboplastin time (PTT) must be within the expected therapeutic range for anticoagulants; Activated partial thromboplastin time (aPTT) or PTT <= 1.5 × ULN; or, if on anticoagulation therapy, PT or aPTT must be within the expected therapeutic range for anticoagulants. 8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. Subjects with abnormal baseline TSH may be enrolled if total T3 (or FT3) and FT4 are within the normal range. 9. Cardiac enzymes within normal limits (isolated laboratory abnormalities judged by the investigator as clinically insignificant are acceptable); 8.Signed informed consent and voluntarily agreed to participate in the clinical research project.
Exclusion criteria
Exclusion criteria: 1.Prior surgical resection, radiotherapy, chemotherapy, targeted therapy, or immunotherapy for head and neck tumors; 2.Recurrent or distant metastatic disease; 3.Any active malignancy within 2 years prior to treatment, except for cancers considered cured (e.g., basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer); 4.Any condition requiring systemic corticosteroid therapy (at a dose >10 mg/day of prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to treatment. 5.Uncontrolled diabetes mellitus within 14 days prior to treatment, or persistent laboratory abnormalities despite standard medical management, including > Grade 1 abnormalities in potassium, sodium, or corrected calcium levels, or >= Grade 3 hypoalbuminemia; 6.History of any of the following conditions: interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary disorders including pulmonary fibrosis and acute lung diseases; 7.Severe chronic or active infections requiring systemic antibiotic, antibacterial, or antiviral treatment (including tuberculosis) within 14 days prior to the first dose of the investigational drug; 8.History of HIV infection; 9.Patients with untreated chronic hepatitis B or active hepatitis C virus (HCV) infection should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, patients with treated and stable hepatitis B (HBV DNA < 500 IU/mL), and patients who have been cured of hepatitis C may be eligible for inclusion; 10.History of severe hypersensitivity reactions to other monoclonal antibodies; 11.Patients who have not recovered to baseline or stabilized from toxicities caused by prior anticancer therapies, unless the adverse events are not considered potential safety risks (e.g., alopecia, neuropathy, or certain laboratory abnormalities); 12.Pregnant or breastfeeding women; 13.Concurrent participation in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;QLQ-H&N35 Quality of Life Questionnaire Score;2-year progression-free survival rate;MPR;2-year overall survival rate.; | — |
Countries
China
Contacts
Public ContactSong Ming
Sun Yat-sen University Cancer Center
Outcome results
None listed