Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

Inclusion Criteria:

1. Male and female patients aged ranging from 18 to 70 years old.

2. Patients with newly histologically proven nasopharyngeal carcinoma (NPC).

3. Local recurrent NPC patients after comprehensive treatment, including clinicalexamination found a clear local area residue: electronic nasopharyngoscope found clearresidual or enlarged cervical lymph nodes.

4. Distant metastatic NPC patients after comprehensive treatment, including liver Bultrasound, chest X-ray, bone scan or other clinicians consider appropriate tests suchas CT, MRI or PET/CT found distant metastases.

5. Comprehensive treatment of local recurrence or distant metastasis after line orsecond-line therapy found progressive disease.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

7. Patient who has the expected survival time more than 3 months.

8. Adequate hematological function: hemoglobin >80 g/L (no transfusion within 14 days),neutrophil count > 1.5×109/L, platelet count 80×109/L.

9. Adequate liver function (serum total bilirubin ≤ 1.5 mg/dL, serum transminase ≤ 2.5times higher than upper limit).

10. Adequate renal function (creatinine clearance ≥ 50 mL/min).

11. Participants volunteered to participate in this study, signed informed consent, goodcompliance and cooperated with us to complete the follow-up.

Exclusion Criteria:

1. Before treatment, MRI showed that the tumor might be an important risk factor (forexample, wrapping around the internal carotid artery / vein); or researchers judgedthat the tumor is a high risk of serious blood vessel bleeding during the treatment.

2. Patient who has serious hemorrhages, any serious bleeding events classification at 3degree or more (according to CTCAE4.0) within the last 4 weeks.

3. Patient who has high blood pressure can not be controlled by a single antihypertensivedrug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); anyunstable angina pectoris; with a history of angina pectoris were newly diagnosed withangina pectoris within 3 months before screening; any myocardial infarction eventsoccurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms,female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart functioninsufficiency ≥II according to New York Heart Association class.

4. Patient who has positive urine protein.

5. Patient who has abnormal coagulation and bleeding tendency (signed informed consentbefore 14 days, and must be satisfied: INR is in the normal range without the use ofanticoagulants); Application of anticoagulants or vitamin K antagonists such as HuaFalin, heparin or its analogues, with international normalized ratio (INR) is lessthan 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or smalldose aspirin (total dose ≤ 100 mg daily).

6. Medical history of arteriovenous thrombosis event within the past year, such ascerebral vascular accident (including transient ischemic attack) and deep venousthrombosis (venous catheter thrombosis caused by chemotherapy and investigator judgedthat the patient had recovered, these patients should be except) and pulmonaryembolism.

7. A healed wound for long time or incomplete fracture.

8. Any factors that affect the oral drug, such as the inability to swallow, diarrhea andintestinal obstruction.

9. For females: patients should be surgical sterilization or postmenopausal patients, orwilling to receive a medical approved contraception during treatment and 6 monthsafter the end of the treatment; serum or urine pregnancy test must be negative, andmust be non lactating period within 7 days before study; for males: patients should betreated with surgical sterilization or willing to receive a medical approvedcontraception during treatment and 6 months after the end of the treatment.

10. History of psychotropic substance abuse and can not be removed or psychiatricdisorders.

11. Medical history of immunodeficiency, or other acquired, congenital immunodeficiencydisease, or history of organ transplantation.

12. Any serious harm to the subject's safety or evidence of significant medical illnessthat in the investigator's judgment will substantially increase the risk associatedwith the subject's participation in and completion of the study.