| Eligibility |
Inclusion Criteria:
1. Males and females; Age:18 to 75 years.
2. Histologically or cytologically confirmed head and neck squamous cell carcinoma
(HNSCC).
3. Patients with resectable locally advanced head and neck squamous cell carcinoma
(LA-HNSCC), classified as stage III-IVB according to the 8th edition of UICC/AJCC
staging.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. No prior treatment for the cancer.
6. Intention to undergo curative treatment.
7. Patients with normal organ function and suitable for immunotherapy combined with
chemotherapy and surgery:
Adequate hematologic function (total white blood cell count = 3.0×10^9/L, absolute
lymphocyte count = 0.8×10^9/L, absolute neutrophil count = 1.5×10^9/L, platelets =
100×10^9/L, hemoglobin = 90g/L); Adequate hepatic function (bilirubin level = 2 times
the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels = 2.5 times ULN); Adequate renal function (serum
creatinine = 1.5 times ULN or calculated creatinine clearance = 60 mL/min
(Cockcroft-Gault formula), urine protein <2+ on dipstick or <1g in a 24-hour urine
collection); Good cardiac function, i.e., normal or clinically insignificant
abnormalities on electrocardiogram (ECG), echocardiogram showing a left ventricular
ejection fraction (LVEF) =50%; Adequate coagulation function: International Normalized
Ratio (INR) or Prothrombin Time (PT) = 1.5 times ULN; participants on anticoagulation
treatment are eligible if the PT is within the therapeutic range of the anticoagulant;
8. Blood pressure well controlled (defined as systolic blood pressure = 150 mmHg and
diastolic blood pressure = 90 mmHg) with or without antihypertensive medication, and
no change in antihypertensive treatment within 1 week before the first dose of study
medication.
9. Patients with HBV infection capable of having detectable HBV DNA levels (=10IU/mL or
above the limit of quantitation) (manifested as positive for hepatitis B surface
antigen (HbsAg) and/or hepatitis B core antibody (anti-HBc)) must receive antiviral
therapy according to clinical practice at the site before randomization to ensure
adequate viral suppression. Patients must maintain antiviral therapy during the study
and for 6 months after the last dose of study treatment. Patients who are anti-HBc
positive but do not have detectable HBV DNA (<10IU/mL or below the limit of
quantitation) are not required to receive antiviral therapy unless their HBV DNA
levels exceed 10IU/mL or the limit of quantitation during treatment.
10. Women of childbearing potential (15-49 years old) must have a negative pregnancy test
within 7 days before starting treatment; patients of childbearing potential must agree
to use effective contraception to ensure they do not become pregnant during the study
period and for 3 months after stopping treatment.
11. Participants voluntarily join the study, sign an informed consent form, have good
compliance, and cooperate with follow-up.
Exclusion Criteria:
1. Patients who have received any form of anti-tumor treatment previously.
2. Patients with allergic constitution and congenital immune deficiencies.
3. Patients who have undergone organ transplantation.
4. Patients with a history of severe bleeding tendencies or coagulation dysfunction;
those who have had clinically significant bleeding symptoms within 1 month prior to
the study treatment, including but not limited to gastrointestinal bleeding,
hemoptysis; those who have received prolonged anticoagulation treatment within 10 days
prior to the study treatment.
5. Patients who have experienced arteriovenous thrombotic events within 6 months before
the study treatment, such as cerebrovascular accidents (including transient ischemic
attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and
pulmonary embolism.
6. Patients with active autoimmune diseases or inflammatory diseases, or a history
thereof, including inflammatory bowel disease (e.g., colitis or Crohn's disease),
diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis
or Wegener's granulomatosis (e.g., granulomatosis with polyangiitis, Graves' disease,
rheumatoid arthritis, hypophysitis, and uveitis). Exceptions to this criterion include
patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone
replacement therapy (e.g., following Hashimoto's thyroiditis); patients with any
chronic skin disease not requiring systemic treatment; inclusion of patients without
active disease in the last 5 years is allowed only after consultation with the study
physician.
7. Patients with active infections, including tuberculosis or human immunodeficiency
virus (HIV 1/2 antibody positive).
8. Patients with uncontrollable complications, including but not limited to: persistent
or active infections receiving study treatment (except HBV or HCV), symptomatic
congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable
angina, uncontrolled arrhythmias, active interstitial lung disease, severe chronic
gastrointestinal disease with diarrhea, or any psychiatric/social situations that
might limit compliance with study requirements, significantly increase the risk of
adverse events (AE), or impair the ability of the patient to give written informed
consent.
9. Pregnant or breastfeeding women.
10. Patients who do not agree to use effective contraception during the treatment period
and for 3 months thereafter.
11. Patients participating in other clinical studies simultaneously.
12. Patients who are critically ill and unable to complete the investigation.
13. Patients with a history of other primary malignant tumors, except for the following:
Malignant tumors treated with curative intent and no known active disease for =5 years
prior to study treatment and with a low risk of relapse; adequately treated
non-melanoma skin cancer or in-situ melanoma without evidence of disease; adequately
treated carcinoma in situ without evidence of disease.
14. Patients with a history of psychiatric illness (e.g., schizophrenia, mania, anxiety
disorder, depression, phobia) or diagnosed with a psychiatric disease at the time of
enrollment or their spouses.
15. Patients or their spouses with communication barriers due to confusion, aphasia,
intellectual disability, or other reasons that prevent normal responses.
16. Patients with other malignant neoplastic diseases.
17. Patients whom the researcher considers unsuitable for inclusion or whose participation
might affect their ability to participate or complete the study for other reasons.
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