Anrotinib and Tirelizumab in First-line Treatment of RM-NPC

Inclusion Criteria:

1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th;the metastatic tissue biopsy is preferred, not necessary; locoregional recurrentlesion unfit for local treatment).
2. Subjects enrolled must have measurable lesion(s) according to response evaluationcriteria in solid (RECIST) v1.1.
3. ECOG performance status of 0～2
4. Life expectancy more than 12 weeks.
5. unable or unwilling to undergo chemothraphy
6. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Uncontrolled clinically significant medical condition, including but not limited tothe following: Hypertension that cannot be reduced to the normal range afterantihypertensive drug congestive heart failure (New York Health Authority Class > 2), unstable angina, myocardial infarction within the past 12 months, clinicallysignificant supraventricular arrhythmia or ventricular arrhythmia requiring treatmentor intervention;
2. Known history of hypersensitivity to any components of the Tirelizumab formulation orother monoclonal antibodies ;
3. Diagnosed with other malignant tumors.
4. Subjects with any active autoimmune disease or history of autoimmune disease, orhistory of syndrome that requires systemic steroids or immunosuppressive medications,including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, andhypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.Subjects with the following conditions will not be excluded from this study: asthmathat requires intermittent use of bronchodilators, hypothyroidism stable on hormonereplacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptionsmay be made with medical monitor approval;
5. Subjects with medical condition affecting oral drug absorption, such as dysphagia,chronic diarrhea and intestinal obstruction.
6. Active bleeding, ulcer, intestinal perforation, major surgery in the previous month;Patients with tumors close to the internal carotid artery or other large vessels, thusat risk of massive bleeding.
7. The laboratory test values within 7 days before enrollment do not meet the relevantstandards.
8. Concurrent medical condition requiring the use of immunosuppressive medications, orimmunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10mg/day prednisone or equivalent are prohibited within 4 weeks before study drugadministration. Note: corticosteroids used for the purpose of IV contrast allergyprophylaxis are allowed;
9. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening; Evidence ofhepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivationbased on institutional guidelines and tests. Testing may include the following: HBVDNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
10. Subjects with comorbidities with long-term immunosuppressive drug therapy, or withsystemic or local use of immunosuppressive doses of corticosteroids.
11. Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any otherantibody acting on T cell synergistic stimulation or checkpoint pathway) andanti-angiogenic drugs.
12. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.)within 4 weeks prior to enrollment.
13. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease),psychiatric, or social condition deemed by the investigator to be likely to interferewith a subject's rights, safety, welfare, or ability to sign informed consent,cooperate, and participate in the study or would interfere with the interpretation ofthe results;