NPC
Conditions
Interventions
Group 2:SHR-1210
Group 1:Apatinib
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-70 years; 2. ECOG PS 0-1 score; 3. Life expectancy= 12weeks; 4. Subjects diagnosed with histologically or cytologically confirmed nasopharyngeal caicinoma, stage IVb according to 8th AJCC staging system or recurrent disease which refused or is not suitable for surgery and radiotherapy; 5. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1 criteria; 6. Patients who fail to receive platinum-based therapy are required to have at least received first-line chemotherapy containing platinum-based regimen The disease progression occurred during the last chemotherapy with platinum-containing regimen <6 months or during chemotherapy with platinum-containing regimen; 7. Function of vital organs meets the following requirements (use of any blood component or cell growth factor is not allowed within 14 days prior to screening): (1) Absolute neutrophil count (ANC) = 1.5 × 10^9/L; (2) Platelets =100×10^9/L; (3) Hemoglobin = 9g/dL; (4) Serum albumin = 2.8g/dL; (5) Bilirubin = 1.5×ULN, ALT and AST = 1.5 × ULN; if there is liver metastasis, ALT and AST = 5 × ULN; (6) Creatinine clearance = 50 mL / min (using the standard Cockcroft-Gault formula, see attachment 3); 8. Women of child-bearing age must have a pregnancy test (serum or urine) within 14 days prior to admission, and the results must be negative, and are willing to use a reliable method of contraception during the trial; 9. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with any active autoimmune disease or a history of autoimmune diseases (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, and hyperthyroidism; 3. Subjects who are using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment; 4. Subjects known to be allergy to any component of study drugs; 5. Subjects having clinical symptoms of metastases to central nervous system (such as cerebral edema requiring steroids intervention, or brain metastasis progression); 6. Patients who have received previous treatment with VEGFR-targeted small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, sunitinib, rigofini, amlotinib, furquintini, etc.); 7. CT/MRI showed tumor invasion of important blood vessels (such as the circumferential internal carotid artery/vein); Or the case that the patient's tumor is highly likely to affect important blood vessels and cause fatal massive hemorrhage during the treatment; 8. Have a history of severe bleeding, and any bleeding events with severe grading up to more than two degrees in CTCAE4.0 within 4 weeks prior to screening; 9. Patients with hypertension who cannot obtain good control through single hypotensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);Clinical significance (such as active) of cardiovascular disease - such as cerebrovascular accident (6 months before the randomization or less), myocardial infarction (6 months before the randomization or less), unstable angina, New York heart association (NYHA) classification of grade II or above of congestive heart failure, or severe arrhythmia drugs control or the test should not be used to treat potentially influence; 10. Patients with active ulcers, perforations and intestinal obstruction; 11. Patients with a history of gastrointestinal perforation within 28 days prior to screening; 12. A variety of factors (such as inability to swallow, postgastrectomy, chronic diarrhea, and intestinal obstruction) that affect the oral and absorption of drugs; 13. Patients with abnormal coagulation function and bleeding tendency (14 days prior to the signing of informed consent: INR is within the normal range without anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues, who's International standardization in prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 14. 6 months prior to screening, Occurred artery or vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (line by chemotherapy venipuncture vein thrombosis by researchers have judgment recovered except) and pulmonary embolism, etc.; 15. Renal insufficiency: routine proteinuria > 2+ and 24-hour urinary protein quantification > 1.0 g; 16. Patients who received strong CYP3A4 inhibitor treatment within one week prior to enrollment or received strong CYP3A4 inducer treatment within two weeks prior to study participation; 17. A wound that has not healed for a long time or a fracture that has not healed properly; 18. Persons who have a history of psychotropic substance abuse and cannot be cured or have a history of mental disord
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events; | — |
Countries
China
Contacts
Public ContactGuopei Zhu
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed