NCT03793725Unknown2 期
A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma
Yanqiao Zhang0 个研究点目标入组 30 人开始时间: 2019年1月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- R0 (resection rate)
研究概览
简要总结
This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.
This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.
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
- •Subjects voluntarily participate in this study and sign informed consent .
- •Men or women aged 18-75 years
- •patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
- •The patients can swallow pills normally.
- •ECOG score was 0 or
- •Have a life expectancy of at least 12 weeks.
- •The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
- •Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
排除标准
- •Subjects had any active autoimmune disease or history of autoimmune disease.
- •Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
- •Subjects with severe allergic reactions to other monoclonal antibodies.
- •The subjects had a central nervous system metastases of clinical symptoms.
- •A heart condition or disease that is not well controlled.
- •Subjects had active infections.
- •Other clinical trials of drugs were used within 4 weeks prior to the first administration.
- •The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
- •There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
研究组 & 干预措施
SHR-1210 + Apatinib
Experimental
Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd
干预措施: SHR1210 (Drug)
SHR-1210 + Apatinib
Experimental
Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd
干预措施: Apatinib (Drug)
结局指标
主要结局
R0 (resection rate)
时间窗: 1 week after surgery
R0 resection rate
次要结局
- ORR(from the first drug administration up to one year)
- RFS(from the first drug administration up to one year)
研究者
Yanqiao Zhang
Director of the hospital
Harbin Medical University
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