| Eligibility |
Inclusion Criteria:
1. Age 18-65 years, both men and women;
2. Patients who diagnosed as Squamous cell carcinoma by pathological examination;
3. Patients who have not received systemic or local treatment for head and neck squamous
cell carcinoma;
4. The primary tumor and lymph nodes can be completely surgically removed;
5. Exclude distant metastasis through chest CT and full-body bone scanning;
6. The patient's vital organs are functioning normally and can tolerate the specified
treatment plan Absolute neutrophil count =1.8 × 109 / L platelets =100 × 109/L,
Hemoglobin =9g/dL, serum albumin =3g/dL Bilirubin=1.5 ULN ALT and AST=2.5 ULN INR=1.5
ULN leukocyte=2000/L Serum creatinine = 1.5 ULN Thyroid Stimulating Hormone= 1 ULN
7. ECOG score:0-1
8. Women of childbearing age (15-49 years old) have a negative serum or urine HCG test
within 7 days before treatment, and agree to use medically approved measures for
contraception during treatment and 120 days after treatment ends
9. Males who have not been sterilized must agree to take effective contraceptive measures
during the study period and at least 120 days after the last dose of PD-1 monoclonal
antibody
10. Patients can provide enough tissue samples for PD-L1 detection or exploratory
research.
11. The patient signs an informed consent and voluntarily participates in the clinical
trial
Exclusion Criteria:
1. Patients who pathologically confirmed non-squamous cell carcinoma
2. Patients who has recurrence or distant metastasis
3. Local lesions have been surgically removed
4. Patients who have received systemic anti-cancer therapy, including hormone therapy
5. Patients who have received treatment targeting PD-1 or PD-L1
6. Patients with active autoimmune disease or a history of autoimmune disease but may
relapse(Patients with the following diseases are not excluded and can be further
filtered)
1. Controlled type 1 diabetes
2. Hypothyroidism(If it can be controlled with hormone replacement therapy)
3. Controlled celiac disease
4. Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis
and Hair loss.
5. Any other disease that is not expected to recur without external triggers
7. Any active malignant tumors within 2 years before treatment, except for the specific
cancers being studied in this trial and locally recurring cancers that have been cured
(such as resected basal cell or squamous cell skin cancer, superficial bladder cancer,
cervical in situ Cancer or breast cancer)
8. Any disease requiring systemic treatment with corticosteroids (referring to treatment
with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs)
or other immunosuppressive treatments within 14 days before treatment.
However, patients who have currently or previously used any of the following steroid
regimens can be selected:
1. Adrenaline replacement steroids(Prednisone =10mg/day or equivalent dose of
similar drugs)
2. Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids which
is Systemic absorbed Minimally
3. Prophylactically short-term (=7 days) use of corticosteroids (for example,
allergy to contrast agents) or for the treatment of non-autoimmune conditions
(for example, delayed hypersensitivity reactions caused by contact allergens)
9. Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with
potassium, sodium and corrected calcium levels> 1 after standard drug treatment or
hypoalbuminemia grade = 3
10. History of the following diseases: interstitial lung disease, non-infectious pneumonia
or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.
11. Severe chronic or active infection (including tuberculosis infection, etc.) that
required systemic antibiotics, antibacterial or antiviral treatment occurred within 14
days before the first administration of the study drug
12. The patient is known to have been infected with HIV
13. Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B
virus (HBV) DNA = 500 IU/mL or active hepatitis C virus carriers (HCV) should be
excluded.
Patients can be selected who is Inactive hepatitis B surface antigen (HBsAg) carriers,
treated and stable hepatitis B patients (HBV DNA <500 IU/mL) and cured hepatitis C
patients.
14. Any surgery requiring general anesthesia has been performed within 28 days before
treatment
15. Have had allogeneic stem cell transplantation or organ transplantation
16. Have any of the following cardiovascular risk factors:
1. Cardiogenic chest pain within 28 days before treatment(moderate pain that
restricts instrumental activities of daily living)
2. Symptomatic pulmonary embolism within 28 days before treatment
3. Acute myocardial infarction within 6 months before treatment
4. Any history of heart failure that has reached Grade III or IV as defined by the
New York Heart Association within 6 months before treatment
5. Grade 2 ventricular arrhythmia within 6 months before the first administration of
the study drug
6. Have a history of cerebrovascular accident within 6 months before the first
administration of the study drug
17. Have a history of severe hypersensitivity to other monoclonal antibodies
18. Patients with treatment toxicity (caused by previous anti-cancer treatments) have not
returned to baseline or stabilized, unless it is an AE that is not considered a
possible safety risk (such as hair loss, neuropathy, or specific laboratory
abnormalities)
19. History of allergic reactions to cisplatin or other platinum-containing compounds
20. Peripheral nerve disease = Grade 2 defined by NCI CTCAE v5.0 standard Have gotten a
live vaccine within 4 weeks before treatment(Seasonal flu vaccines are usually
inactivated vaccines and are allowed to be used; The vaccine used in the nasal cavity
is a live vaccine and is not allowed to be used)
21. Abuse or dependence on alcohol or drugs and Basic medical conditions (including
laboratory abnormalities) that are not conducive to the administration of the study
drug , affect the interpretation of drug toxicity or AEs, lead to insufficient
compliance with the study execution and possible damage
22. The patient participates in another therapeutic clinical study at the same time
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