NCT02449343Unknown2 期
A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 233
- 试验地点
- 25
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease.
- •Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
- •18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
- •Main organs function is normal
- •The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
排除标准
- •Prior treatment with Anlotinib
- •With pleural effusion or ascites, cause respiratory syndrome
- •Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
- •Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
- •Symptoms of brain metastases cannot be controlled and treated within less than 2 months
- •With severe and failed to controlled diseases
- •Occurred venous thromboembolic events within 6 months
研究组 & 干预措施
Anlotinib
Experimental
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Placebo
Placebo Comparator
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Placebo (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: up to 24 months
次要结局
- Overall Survival (OS)(up to 24 months)
- Objective Response Rate (ORR)(up to 24 months)
- Disease Control Rate (DCR)(up to 24 months)
研究者
研究点 (25)
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