Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

• Locally advanced squamous cell carcinoma of the head and neck (AJCC8thIII-IV)confirmed by pathology in the initial treatment;
• No residual lesions after first-line surgery/radiotherapy/chemotherapy/targetedcomprehensive treatment;
• Associated high risk factors: T3-4, regional lymph node positive, vascular invasion,neural invasion, lymph node capsular invasion, incisional margin positive;
• The patients' age is between 18 and 70 years old;
• The ECOG physical fitness status score is 0 or 1;
• Estimated survival period ≥ 3 months;
• The main organ functions meet the following standards: (1) Blood routine (withoutblood transfusion within 14 days): HGB ≥ 110g /L, WBC ≥ 3.0 × 10^9/L， NEUT≥1.5 × 10^9/L，PLT ≥75 × 10^9/L； (2) Biochemical: BIL ≤ 1.5 times the upper limit of normalvalue (ULN), ALT and AST ≤ 2.0 × ULN, serum Cr ≤ 1.5 × ULN or endogenous creatinineclearance ≥ 50ml /min; (3) Occult blood in stool (-); (4) Normal urine routine, orurine protein<(++), or 24-hour urine protein<1.0g; (5) Left ventricular ejectionfraction (LVEF) ≥ 50%. (6) The blood coagulation function is normal, and there is noactive bleeding or thrombosis disease. A. International standardized ratio INR ≤ 1.5 ×ULN； B. Partial thromboplastin time APTT ≤ 1.5 × ULN； C. Prothrombin time PT ≤ 1.5ULN. (7) Thyroid stimulating hormone (TSH) ≤ 1.5ULN; If the T3 and T4 levels are abnormal,they should be investigated. If the T3 and T4 levels are normal, they can be selected;
• Women of childbearing age should agree to use contraceptives (such as intrauterinedevices, birth control pills, or condoms) during and within 3 months after the end ofmedication; "Within 7 days prior to study enrollment, the serum or urine pregnancytest was negative and must be a non lactating patient. The male should agree to usecontraception during the study period and within 3 months after the end of the studyperiod;
• Patients with hepatitis B virus (HBV) infection, inactive/asymptomatic HBV carriers,or patients with chronic or active HBV who received antiviral therapy for>1 week atthe time of screening are allowed to be enrolled and continue treatment for more than 6 months after the study drug treatment. Patients with positive hepatitis C antibodieswho have started anti hepatitis C virus treatment at the time of screening will beallowed to participate in the group;
• Subjects voluntarily joined the study, signed an informed consent form, had goodcompliance, and cooperated with follow-up.

Exclusion Criteria:

• Distant metastasis of the tumor was detected upon enrollment;
• Have a history of allergy to PD-1 monoclonal antibody or drug components;
• There has been a history of other malignant tumors within the past 5 years or at thesame time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, andthyroid papillary carcinoma;
• Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure aboveNYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4)patients with clinically significant supraventricular or ventricular arrhythmiasrequiring clinical intervention;
• Have received any of the following treatments: a. Have previously received treatmentwith immunosuppressive drugs; B. Have received any investigational drug within 4 weeksbefore the first use of the investigational drug; C. Joining another clinical study atthe same time, unless it is an observational (non intervention) clinical study or anintervention clinical study follow-up; D. Subjects who require systemic treatment withcorticosteroids (greater than 10 mg prednisone equivalent dose per day) or otherimmunosuppressants within 2 weeks prior to the first use of the study drug, excludingthe use of corticosteroids for local inflammation and the prevention of allergies,nausea, and vomiting. In the absence of active autoimmune diseases, it is allowed toinhale or locally use steroids and adrenal cortical hormone replacement with a dosegreater than 10 mg/day of prednisone; E. Have received an anti-tumor vaccine or a livevaccine within 4 weeks before the first administration of the study drug; F. Majorsurgery or severe trauma requiring removal of the disease within 4 weeks before thefirst use of the study drug;
• Serious infections (CTCAE greater than Level 2) occurred within 4 weeks before thefirst use of the study drug, such as severe pneumonia, intracranial infection, etc.that require hospitalization;
• Have a history of active autoimmune diseases and autoimmune diseases, but does notinclude autoimmune mediated hypothyroidism treated with stable doses of thyroidreplacement hormone; Type I diabetes with a stable dose of insulin; Patients withvitiligo or recovered childhood asthma/allergies who do not require any interventionin adulthood;
• Have a history of immunodeficiency, including HIV testing positive, or have otheracquired or congenital immunodeficiency diseases, or have a history of organtransplantation and bone marrow transplantation;
• Have a history of interstitial lung disease and non infectious pneumonia;
• Patients who have a history of active pulmonary tuberculosis infection through medicalhistory or CT examination, or who have a history of active pulmonary tuberculosisinfection within 1 year before enrollment, or who have a history of active pulmonarytuberculosis infection before 1 year but have not received formal treatment;
• Subjects with active hepatitis (HBV DNA ≥ 2000 IU /ml or 10000 copies /ml) who havenot been treated, and hepatitis C (hepatitis C antibody positive, and HCV-RNA abovethe detection limit of the analytical method) who have not been treated;
• Known history of abuse, alcoholism, and drug abuse of psychotropic substances;
• KPS score<60, intolerance to anti-tumor therapy;
• Pregnant or lactating women;
• Engaging or expected to participate in other clinical studies;
• Researchers believe that it is not suitable for inclusion.