NCT06125171尚未招募2 期
A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma
Wuhan Union Hospital, China0 个研究点目标入组 46 人开始时间: 2024年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- 6-month progression-free survival rate
研究概览
简要总结
This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.
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
- 年龄范围
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥10 years, ≤ 75 years;
- •Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
- •Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
- •Eastern Collaborative Oncology Group (ECOG) 0~2；
- •Tumor size is measurable according to RECIST1.1 criteria；
- •Adequate organ function；
- •Life expectancy is more than 3 months；
- •Willing and able to provide written informed consent.
排除标准
- •Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
- •Urine protein≥ ++;
- •FBG>10mmol/L;
- •Uncontrolled blodd pressure (ystolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg);
- •Known active CNS metastases and/or carcinomatous meningitis;
- •Not able to take medicine orally;
- •Coagulant function abnormality (PT>16s, APTT> 43s, TT>21s, FIB）<2g/L);
- •Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease;
- •Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
研究组 & 干预措施
Tucidinostat+Apatinib
Experimental
干预措施: Tucidinostat, Apatinib (Drug)
结局指标
主要结局
6-month progression-free survival rate
时间窗: 6 months
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment
次要结局
- Progression-free survival(PFS)(2 years)
- Objective Response Rate（ORR）(2 years)
- Disease Control Rate （DCR）(2 years)
- Overall survival(OS)(2 years)
研究者
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