Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients.
Age 18-75 years old;
ECOG PS score of 0-1;
Pathologically confirmed, untreated patients with head and neck squamous cell carcinoma, classified as stage III, IVa according to AJCC (8th edition), including hypopharyngeal cancer, laryngeal cancer, and oral cancer;
Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone sterilization. For male participants, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone surgical sterilization;
Received previous PD-1/PD-L1/CTLA-4 antibody therapy;
Tumor invasion of major blood vessels;
Patients requiring systemic use of glucocorticoids (>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days before administration or during treatment. Inhaled or local use of steroids and adrenal corticosteroids at doses >10mg/day prednisone equivalent are allowed in the absence of active autoimmune diseases. Adrenal corticosteroid replacement therapy not exceeding 10mg/day prednisone equivalent is also allowed;
Presence of any history of active immune or autoimmune diseases, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor