NCT03268772Unknown2 期
Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic 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
- 40
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).
详细描述
This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years with histologically confirmed advanced or metastatic STS
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •life expectancy of ≥ 3 months
- •have not received chemotherapy before
- •at least one measurable lesion
- •have adequate bone marrow, hepatic, and renal function
排除标准
- •osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans
- •patients with symptomatic brain metastases
- •active clinical severe infection
研究组 & 干预措施
PLD-IFO
Experimental
pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)
干预措施: PLD and IFO (Drug)
结局指标
主要结局
progression free survival
时间窗: 6 months
次要结局
- biomarker analysis(6 months)
- overall response rate(2 months)
- overall survival(12 months)
- Adverse Events(2 months)
研究者
Zhiguo Luo, MD, PhD
Vice professor
Fudan University
研究点 (1)
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