NCT04172571已完成2 期
An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma
Akeso1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.
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
- •Signed written informed consent form voluntarily.
- •Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- •Expected life expectance ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or
- •Confirmation either by histology unresectable hepatocellular carcinoma..
- •BCLC stage C, and non-resectable BCLC stage B .
- •No prior systemic therapy for HCC.
- •Child-Pugh class A and B (≤7 points).
- •At least one measurable lesion according to RECIST criteria.
- •Adequate hematologic and end-organ function.
- •For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.
排除标准
- •Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
- •Active ongoing infection requiring therapy.
- •History of severe hypersensitivity reaction to another monoclonal antibody.
- •Received any live attenuated vaccine within the last 30 days.
- •Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
- •Pregnant, breast feeding, or planning to become pregnant.
- •Active or prior documented autoimmune or inflammatory disease with some exceptions.
- •Central nervous system metastases and/or carcinomatous meningitis.
- •Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
- •Co-infection of HBV and HCV.
- •Inadequately controlled arterial hypertension.
研究组 & 干预措施
AK105 and anlotinib
Experimental
干预措施: AK105 (Biological)
AK105 and anlotinib
Experimental
干预措施: Anlotinib Hydrochloride (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to approximately 18 months
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
次要结局
- Duration of response (DoR)(up to approximately 18 months)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through 90 days after last dose of AK105)
- Number of subjects experiencing adverse events (AEs)(From the time of informed consent through 90 days after last dose of AK105)
- Progression-free survival (PFS)(up to approximately 18 months)
- Disease control rate (DCR)(up to approximately 18 months)
- Overall survival (OS)(up to approximately 24 months)
- Observed concentrations of AK105(From first dose of AK105 through 90 days after last dose of AK105)
研究者
研究点 (1)
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