Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC

Inclusion Criteria:

1. Histological or cytological examination confirmed recurrence or metastasis ofnasopharyngeal carcinoma;

2. Patients who have not previously received systemic treatment for recurrent ormetastatic diseases (For patients who have previously received inductionchemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy, patients whorelapsed at least 6 months after the cessation of chemotherapy can be enrolled).

3. Age: 18-75 years old, male or female;

4. Perfomance Status: 0~1;

5. At least one measurable lesion (according to RECIST v1.1, long diameter ofmeasurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter ofswollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, apreviously treated lesion with local treatment can be used as target lesions afterclear progress);

6. Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L;

7. Liver function: 1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 ×ULN; if liver metastasis, ALT and AST ≤ 5 × ULN; Renal function: Albumin ≥ 28g / L ；Serum creatinine (Cr) ≤ 1.5 × ULN，or creatinine clearance rate ≥ 60 ml / min ;

8. Coagulation function : APTT and international normalized ratio (INR)< 1.5 × UNL;

9. Patients of childbearing age agree to take appropriate contraceptive measures. Serumpregnancy test was negative in women of childbearing age within 2 weeks beforeenrollment.

10. Patients agree to provide pathological tissue specimens (wax blocks or paraffintissue sections 5-10 pieces) ;

11. Expected survival ≥ 3 months;

12. Patients volunteered to participate in this study and signed informed consent;

Exclusion Criteria:

1. Patients with local recurrence and suitable for surgery or radiotherapy;

2. Patients with a known history of severe allergies to monoclonal antibody therapy;

3. Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonalantibody or CTLA4 monoclonal antibody;

4. Clinical significance of heart disease, including severe cardiac insufficiency : NewYork Heart Association (NYHA) cardiac insufficiency grade IV, unstable angina, acutemyocardial infarction within 6 months before screening, congestive heart failure,Q-Tc interval greater than 500ms;

5. Patients with autoimmune diseases requiring treatment, or patients with a history ofsystemic use of steroids / immunosuppressive agents, such as : hypophysitis,pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism;

6. Other serious and uncontrollable concomitant diseases that may affect the complianceof the program or interfere with the interpretation of the results, includinguncontrolled diabetes, or lung diseases (interstitial pneumonia, obstructivepulmonary disease, and symptomatic bronchial spasm) ;

7. Known hepatitis B (HBV) (HBsAg positive and HBV-DNA ≥ 103IU / ml), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA measurable) ; and other subjectswith acquired and congenital immunodeficiency diseases, including, but not limitedto, those infected with HIV;

8. Severe active infection;

9. Symptomatic patients with central nervous system metastasis;

10. Patients with a history of other malignant tumors (unless those who have been curedfor more than 5 years);

11. Have a serious history of neurological or psychiatric disorders, including dementiaor epilepsy;

12. Drug abuse, medical, psychological or social conditions that may interfere with theparticipant 's participation in the study or the evaluation of the study results;

13. Researchers believe that patients who are not suitable for enrollment.