Clinical trial NCT03130270 (phase 2, status: unknown status)
Conditions: nasopharyngeal carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: apatinib mesylate tablet
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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 clinical
             examination found a clear local area residue: electronic nasopharyngoscope found clear
             residual or enlarged cervical lymph nodes.

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

          5. Comprehensive treatment of local recurrence or distant metastasis after line or
             second-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 ≤ 2.5
             times higher than upper limit).

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

         11. Participants volunteered to participate in this study, signed informed consent, good
             compliance 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 (for
             example, wrapping around the internal carotid artery / vein); or researchers judged
             that 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 3
             degree 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 antihypertensive
             drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); any
             unstable angina pectoris; with a history of angina pectoris were newly diagnosed with
             angina pectoris within 3 months before screening; any myocardial infarction events
             occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms,
             female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function
             insufficiency ≥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 consent
             before 14 days, and must be satisfied: INR is in the normal range without the use of
             anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua
             Falin, heparin or its analogues, with international normalized ratio (INR) is less
             than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small
             dose aspirin (total dose ≤ 100 mg daily).

          6. Medical history of arteriovenous thrombosis event within the past year, such as
             cerebral vascular accident (including transient ischemic attack) and deep venous
             thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged
             that the patient had recovered, these patients should be except) and pulmonary
             embolism.

          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 and
             intestinal obstruction.

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

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

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

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