| Eligibility |
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/targeted
comprehensive 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 (without
blood 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 normal
value (ULN), ALT and AST = 2.0 × ULN, serum Cr = 1.5 × ULN or endogenous creatinine
clearance = 50ml /min; (3) Occult blood in stool (-); (4) Normal urine routine, or
urine protein<(++), or 24-hour urine protein<1.0g; (5) Left ventricular ejection
fraction (LVEF) = 50%. (6) The blood coagulation function is normal, and there is no
active 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 intrauterine
devices, birth control pills, or condoms) during and within 3 months after the end of
medication; "Within 7 days prior to study enrollment, the serum or urine pregnancy
test was negative and must be a non lactating patient. The male should agree to use
contraception during the study period and within 3 months after the end of the study
period;
- 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 at
the 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 antibodies
who have started anti hepatitis C virus treatment at the time of screening will be
allowed to participate in the group;
- Subjects voluntarily joined the study, signed an informed consent form, had good
compliance, 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 the
same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and
thyroid papillary carcinoma;
- Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure above
NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4)
patients with clinically significant supraventricular or ventricular arrhythmias
requiring clinical intervention;
- Have received any of the following treatments: a. Have previously received treatment
with immunosuppressive drugs; B. Have received any investigational drug within 4 weeks
before the first use of the investigational drug; C. Joining another clinical study at
the same time, unless it is an observational (non intervention) clinical study or an
intervention clinical study follow-up; D. Subjects who require systemic treatment with
corticosteroids (greater than 10 mg prednisone equivalent dose per day) or other
immunosuppressants within 2 weeks prior to the first use of the study drug, excluding
the use of corticosteroids for local inflammation and the prevention of allergies,
nausea, and vomiting. In the absence of active autoimmune diseases, it is allowed to
inhale or locally use steroids and adrenal cortical hormone replacement with a dose
greater than 10 mg/day of prednisone; E. Have received an anti-tumor vaccine or a live
vaccine within 4 weeks before the first administration of the study drug; F. Major
surgery or severe trauma requiring removal of the disease within 4 weeks before the
first use of the study drug;
- Serious infections (CTCAE greater than Level 2) occurred within 4 weeks before the
first 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 not
include autoimmune mediated hypothyroidism treated with stable doses of thyroid
replacement hormone; Type I diabetes with a stable dose of insulin; Patients with
vitiligo or recovered childhood asthma/allergies who do not require any intervention
in adulthood;
- Have a history of immunodeficiency, including HIV testing positive, or have other
acquired or congenital immunodeficiency diseases, or have a history of organ
transplantation 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 medical
history or CT examination, or who have a history of active pulmonary tuberculosis
infection within 1 year before enrollment, or who have a history of active pulmonary
tuberculosis infection before 1 year but have not received formal treatment;
- Subjects with active hepatitis (HBV DNA = 2000 IU /ml or 10000 copies /ml) who have
not been treated, and hepatitis C (hepatitis C antibody positive, and HCV-RNA above
the 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.
|
