NCT03711279终止2 期
A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin (ADM) Plus Ifosfamide (IFO) in Patients With Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants 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
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with the age from 16 years to 70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation.
- •Life expectancy of at least 3 months.
- •Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.The histopathologic types as specified in the protocol.
- •Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy.
- •Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- •Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol.
- •Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug.
- •Willingness to comply with the study protocol for any reason.
排除标准
- •Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug.
- •Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs.
- •Plan to receive surgery or radiotherapy to treat the sarcoma during the trail.
- •Radiological evidence of brain metastases or primary tumors.
- •Diagnosed other malignancies within the last 3 years from the first dose of drug.
- •Known allergy to any of the treatment components.
- •Active infection including human immunodeficiency virus (HIV) ,HBV or HCV.
- •Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
研究组 & 干预措施
SHR-1210 plus Apatinib
Experimental
干预措施: SHR-1210 plus Apatinib (Drug)
ADM plus IFO or IFO alone
Active Comparator
干预措施: ADM plus IFO or IFO alone (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.
Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions)
次要结局
- Objective Response Rate (ORR)(From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.)
研究者
研究点 (1)
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