Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Interventions
Experimental group:Trepilimab, albumin-bound paclitaxel, cisplatin
Sponsors
The First People's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years, male or female; 2. Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx); 3. Clinically staged as III or IV (according to AJCC 8th edition) locally advanced HNSCC (LA-HNSCC) that is surgically resectable, with at least one measurable lesion (per RECIST criteria), and no evidence of distant metastasis; 4. ECOG Performance Status score: 0-1; 5. Imaging studies show no evidence of distant metastasis; 6. Expected survival >=6 months; 7. Normal function of major organs, meeting the following criteria: (1).matological tests must meet (no blood transfusion within 14 days prior to screening): 1) . Hemoglobin (HB) >=80 g/L; 2). Absolute Neutrophil Count (ANC) >=1.0 × 10^9/L; 3). Platelets (PLT) >=80 × 10^9/L. (2)Biochemical tests must meet the following standards (no blood or blood product transfusion within 14 days prior to screening): 1). Total Bilirubin (BIL) =1 will be enrolled; * CPS = (Number of PD-L1 membrane-staining positive tumor cells + Number of PD-L1 positive tumor-associated immune cells) / Total number of tumor cells × 100. 9. Patient has no known immune system diseases, such as systemic lupus erythematosus or other autoimmune diseases, that may affect the safety or efficacy of immunotherapy. Patient has no history of taking immunosuppressants or is not receiving long-term immunosuppressive therapy; 10. Patient has not received prior systemic chemotherapy, radiotherapy, or immunotherapy for head and neck cancer. Local treatments such as surgery or ablation are allowed but must have been completed at least 4 weeks prior to enrollment, with good recovery from such treatment; 11. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be willing to use reliable methods of contraception during the trial. Male subjects must agree to use reliable contraception from the start of treatment until 120 days after the last dose; 12. The subject voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation, or planning to become pregnant during the study period; 2. Presence of active autoimmune diseases or immunodeficiency disorders, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or a history of such conditions or organ transplantation; 3. Positive HIV test result; 4. Receipt of systemic immunosuppressive drug therapy within 2 weeks prior to the start of study treatment, or anticipated need for systemic immunosuppressive drug therapy during the study; 5. Receipt of systemic immunostimulant therapy (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to the start of study treatment or still within 5 drug half-lives (whichever is longer); 6. History of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ; 7. Occurrence of severe cardiovascular diseases within 3 months prior to the start of study treatment (e.g., NYHA Class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina; 8. Active infection or contagious disease, or unexplained fever (body temperature > 38.5°C) during screening or before the first dose; 9. Receipt of therapeutic oral or intravenous antibiotics within 2 weeks prior to the start of study treatment. Patients receiving prophylactic antibiotic therapy (e.g., for urinary tract infections or chronic obstructive pulmonary disease) may be enrolled; 10. Untreated active hepatitis (Hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA >= 10^4 IU/mL; Hepatitis C: HCV-RNA >= 10^3 IU/mL or requiring antiviral therapy during the study period); 11. Receipt of immunotherapy such as PD-1/L1 or CTLA-4 antibodies within 4 weeks prior to enrollment; receipt of chemotherapy or targeted therapy within 4 weeks prior to enrollment; 12. Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment; 13. Potential need for other anti-tumor therapies during the study period; 14. Potential need for vaccination during the study period or receipt of vaccination within 4 weeks prior to enrollment; 15. Other severe comorbidities that, in the investigator’s judgment, may endanger the patient’s safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Major pathological response;2-year progression-free survival rate;2-year and 5-year survival rates;Safety profile; | — |
Countries
China
Contacts
Public ContactZeng Rong
The First People's Hospital of Yunnan Province
Outcome results
None listed