EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma

Inclusion Criteria:

• Patients with nasopharyngeal carcinoma who have recurred/metastasized after initialtreatment or radical treatment;

• Age 18-75, male or female;

• Pathological diagnosis of nasopharyngeal carcinoma;

• ECOG score 0-1;

• Have not previously received any anti-tumor therapy such as radiotherapy,chemotherapy, immunotherapy or biotherapy for recurrence/metastasis;

• No contraindications of chemotherapy, immunotherapy and targeted therapy;

• At least 1 measurable lesion that meets RECIST 1.1 criteria;

• Blood routine examination standards should meet: WBC≥3.0×109/L, ANC≥1.5×109/L,PLT≥100×109/L, HGB≥90g/L (no blood transfusion and blood products within 14 days, noG-CSF and other hematopoietic stimulating factors are used to correct);

• Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT,AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml/min (Cockcroft-Gault formula);

• Good coagulation function: defined as International standardized ratio (INR) orprothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulanttherapy, as long as PT is within the intended range of anticoagulant drug use;

• The myocardial enzyme spectra were in the normal range;

• Women of childbearing age must already be using reliable contraception or have had apregnancy test (serum or urine) within 7 days of enrollment with a negative resultand be willing to use an effective method of contraception during the trial and for 3 months after the last anti-PD-1 antibody administration. For male subjects whosepartners are women of reproductive age, effective contraception should be usedduring the trial and within 3 months after the last anti-PD-1 antibodyadministration;

• The subjects voluntarily joined the study, signed informed consent, had goodcompliance, and cooperated with follow-up;

Exclusion Criteria:

• Patients with recurrence who can be treated with local resection or radiotherapy;

• Known to be allergic to the investigational drug or any excipients thereof, or hashad a severe allergic reaction to other monoclonal antibodies;

• Patients have symptoms of central nervous system metastasis such as brain edema andneed hormonal intervention;

• Had an active infection or unexplained fever >38.5℃ during screening or prior to thefirst dose (the investigator determined that the subject's fever due to the tumorcould be enrolled);

• Have any active autoimmune disease or history of autoimmune disease (e.g.,interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be included afternormal hormone replacement therapy]); Patients with vitiligo or complete remissionof asthma in childhood without any intervention as adults could be included, butpatients with asthma requiring medical intervention with bronchodilators could notbe included;

• Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B (HBV-DNA≥103 copy number /ml), or hepatitis C (hepatitis C antibody positive andHCR-RNA above the lower detection limit of analytical methods);

• Previous or co-existing uncured malignancies, except cured basal cell carcinoma ofthe skin, carcinoma in situ of the cervix and superficial bladder cancer;

• Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia ormyocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards,or left ventricular ejection fraction (LVEF) <50% indicated by cardiac colorultrasound; Myocardial infarction within 1 year;

• If the subject has undergone major surgery, the toxic effects and/or complicationsof the surgical intervention must be fully recovered before treatment is initiated;

• Within 4 weeks prior to the first use of the investigational drug (participants inthe follow-up period are counted as the last use of the investigational drug ordevice) or are currently participating in another clinical study;

• Live vaccine received within 4 weeks prior to the first administration of theinvestigational drug is allowed to receive inactivated virus vaccine for seasonalinfluenza by injection, but not live attenuated influenza vaccine for nasaladministration;

• Pregnant or lactating women;

• In the investigator's judgment, the subjects had other factors that might have ledto their forced discontinuation of the study, such as other serious medicalconditions (including mental illness) requiring concomitant treatment, seriousabnormalities in laboratory test values, or family or social factors that might haveaffected the safety of the subjects or the circumstances of the trial datacollection.