NCT04346381已完成2 期
An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
- •Willing to provide tumor tissue for PD-L1 biomarker analysis.
- •At least one measurable lesion according to RECIST 1.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •Signing the informed consent forms.
- •Adequate bone marrow, liver and renal function.
排除标准
- •Subjects with untreated central nervous system (CNS) metastases.
- •Subjects with an active, known or suspected autoimmune disease.
- •Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- •Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- •Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- •Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
- •Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
研究组 & 干预措施
camrelizumab combined with famitinib
Experimental
Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.
干预措施: Camrelizumab (Drug)
camrelizumab combined with famitinib
Experimental
Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.
干预措施: Famitinib (Drug)
结局指标
主要结局
Response Rate
时间窗: Up to 18 months
Response Rate
次要结局
- PFS(Up to 18 months)
- DOR(Up to 18months)
- DCR(Up to 18months)
- TTR(Up to 18 months)
- OS(Up to 18 months)
- Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline(Up to 18 months)
- Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.(Up to 18 months)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0(Up to 18 months)
- Plasma concentration of famitinib(Up to 18 months)
- Serum concentration of camrelizumab(Up to 18 months)
研究者
研究点 (1)
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