A Phase II Study of Anlotinib in STS Patients
关键词
抽象
日期
| 最后验证: | 04/30/2019 |
| 首次提交: | 05/29/2013 |
| 提交的预估入学人数: | 06/11/2013 |
| 首次发布: | 06/16/2013 |
| 上次提交的更新: | 05/19/2019 |
| 最近更新发布: | 05/21/2019 |
| 实际学习开始日期: | 03/31/2013 |
| 预计主要完成日期: | 09/30/2015 |
| 预计完成日期: | 04/29/2017 |
状况或疾病
干预/治疗
Drug: Anlotinib
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Anlotinib | Drug: Anlotinib |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT - 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF - LLN. 5.Used contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: - 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases. |
结果
主要结果指标
1. tumor size [each 42 days up to 48 months]
次要成果指标
1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [each 21 days up to 48 months]
