A Study of Carilizumab in Combination With Apatinib in Subjects With Unresectable UPS and ASPS

Who cannot join

• Known active central nervous system (CNS) metastasis and / or cancerous meningitis. Subjects who had previously received brain metastases may participate as long as they are stable and meet the following criteria: there is no evidence of imaging progress for at least four weeks prior to the first dose of trial treatment, and any neurological symptoms have returned to baseline, there is no evidence of new or expanded brain metastases, and steroids are not used for at least seven days prior to the trial treatment. This exception does not include cancerous meningitis, regardless of its clinical stability;
• Immunosuppressive drugs were used within 14 days before the first use of carrizumab, excluding nasal spray and inhaled corticosteroids or systemic steroids with physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids with physiological dose of the same drug); 3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (for example, CTLA-4, OX-40, CD137); 4. Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite systematic medication); 5. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poor control of arrhythmia (including QTc interval ≥ 450 ms for men and 470 MS for women); cardiac insufficiency of grade III-IV (according to NYHA classification of New York Heart Association, see Annex 3), or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler echocardiography; 6. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) shall not be included; 7. The subjects received systematic treatment such as bronchodilator, and the asthma control was not satisfactory and could not be included (the asthma in childhood has been completely relieved, and the adult can be included without any intervention); 8. Routine urine test indicated that urine protein was ≥ 1.0g, or 24-hour urine protein was ≥ 1.0g; 9. Abnormal coagulation (INR > 1.5 ULN or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; Note: on the premise that the international standard ratio of prothrombin time (INR) is less than or equal to 1.5, it is allowed to use low-dose heparin (6000-12000 u daily for adults) or aspirin (less than or equal to 100 mg daily) for prevention purposes; 10. Severe infection (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening / before the first administration > 38.5 ° C; 11. Serious arteriovenous thrombotic events occurred in the first 12 months, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 12. In the first 4 weeks of the group, they had undergone major surgery or had severe traumatic injury, fracture or ulcer; 13. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C; 14. Patients with a clear history of allergy may be potentially allergic or intolerant to the biological agents of apatinib and carrizumab; 15. There are obvious factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or there were cavity organ sinus or perforation within 6 months; 16. Those who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders; 17. Increase the risk associated with participating in the study or study drug, and other circumstances that, in the judgment of the investigator, may result in the patient not being eligible for inclusion in the study.