NCT04260113已完成不适用
The Effectivity and Toxicity of Apatinib for Unresectable Advanced Chondrosarcoma: a Multicentric Retrospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- progression-free survival
研究概览
简要总结
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed high-grade sarcoma;
- •initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University;
- •tumors not amenable to curative treatment or inclusion in clinical trials;
- •unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
- •measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ;
- •Eastern Cooperative Oncology Group performance status 0 or 1;
- •acceptable hematologic, hepatic, and renal function.
排除标准
- •had central nervous system metastasis;
- •had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- •had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
- •had pleural or peritoneal effusion that needs to be handled by surgical treatment;
- •combined with other infections or wounds;
- •pregnant or breastfeeding.
研究组 & 干预措施
Apatinib Arm
Experimental
干预措施: Apatinib Mesylate (Drug)
结局指标
主要结局
progression-free survival
时间窗: 6 months
from initial treatment to date of recorded progression or death or last follow-up
次要结局
- objective response rate(6 months)
- overall survival(5 years)
- clinical benefit rate(6 months)
研究者
研究点 (2)
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