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;
Single group
Benmelstobart
Drug1200mg, D1, IV,q3w
Anlotinib
Drug10mg，D1-14，po，q3w
Cisplatin
Drug60mg/m2， D1， IV，q3w
Paclitaxel for Injection （Albumin Bound）
Drug260mg/m2，IVgtt ，D1，q3w
Major pathological response，MPR
It is defined as pathological examination shows that the tissue sample has ≤10% viable tumor, i.e. the area of residual viable tumor cell region/surface area of tumor bed ≤10%.
Objective response rate (ORR) evaluated by RECIST 1.1
The proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including cases of complete response (CR) and partial response (PR). The tumor's objective response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).
Pathological complete remission rate (pCR)
Defined as pathological examination showing 0% viable tumor tissue (0% RVT); calculate the proportion of subjects achieving pathological complete remission (pCR).
Disease-free survival rate at 2 years
The proportion of subjects who experienced disease recurrence or died (from any cause) from enrollment to the end of the first year, out of the total number of subjects.
Locoregional recurrence-free survival rate (LRFS) at 2 years
The proportion of subjects who did not experience local or regional lymph node recurrence or death from enrollment to the end of the second year, out of the total number of subjects.
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