A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
试验速览
- 阶段
- 3 期
- 入组人数
- 256
- 试验地点
- 3
- 主要终点
- Progression free survival (PFS) assessed by independent review committees (IRC)
研究概览
简要总结
A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy >=3 months.
- •Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- •Understood and signed an informed consent form.
排除标准
- •Diagnosed and/or treated additional malignancy within 5 years before the first dose.
- •With factors affecting oral medication.
- •Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
- •A history of psychotropic drug abuse or have a mental disorder.
- •Any severe and/or uncontrolled diseas.
- •Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.
- •Has participated in other clinical studies within 4 weeks before the first dose.
- •According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
Arotinib hydrochloride capsule + Epirubicin
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
干预措施: Anlotinib hydrochloride capsule (Drug)
Arotinib hydrochloride capsule + Epirubicin
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
干预措施: Epirubicin (Drug)
Placebo + Epirubicin
Placebo combined with epirubicin, 21 days as a treatment cycle
干预措施: Epirubicin (Drug)
Placebo + Epirubicin
Placebo combined with epirubicin, 21 days as a treatment cycle
干预措施: Arotinib hydrochloride capsule placebo (Drug)
结局指标
主要结局
Progression free survival (PFS) assessed by independent review committees (IRC)
时间窗: Baseline up to 12 months
Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first
次要结局
- Overall survival (OS)(Baseline up to die)
- progression free survival (PFS) assessed by investigator(Baseline up to 12 months)
- Objective response rate (ORR)(Baseline up to 6 months)
- Disease control rate (DCR)(Baseline up to 25 months)
- Duration of overall response (DOR)(Baseline up to 6 months)
- Degradation rate(Baseline up to 6 months)