NCT04542837已完成2 期
A Phase II Study Evaluating the Safety and Efficacy of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
Peking University Cancer Hospital & Institute2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年9月11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
- 55
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced 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
- •Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
- •Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
- •Age ≥18 years or ≤75 years for both genders；
- •ECOG performance status: 0-1；
- •Child Pugh score≤7；
- •LVEF≥50% or above LLN of the research institution；
- •Enough organ function；
- •Has at least one measurable lesion based on RECIST 1.1；
- •Life expectancy ≥3 months；
- •Patients must be able to understand and willing to sign a written informed consent document；
排除标准
- •Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
- •Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
- •Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
- •Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
- •Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
- •Any previous or current active autoimmune disease or history of autoimmune disease;
- •History of hepatic encephalopathy or liver transplantation;
- •History of interstitial lung disease or non-infectious pneumonia;
- •History of allergic reactions to related drugs;
- •Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
- •With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
- •Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
- •Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive;
- •Evidence of active pulmonary tuberculosis (TB);
- •Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- •Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;
研究组 & 干预措施
KN046 plus Lenvatinib
Experimental
干预措施: KN046 (Biological)
KN046 plus Lenvatinib
Experimental
干预措施: Lenvatinib (Drug)
结局指标
主要结局
ORR
时间窗: 1 year after the last patient's enrollment
objective response rate (ORR) based on the RECIST 1.1 by investigator
次要结局
- DOR(1 year after the last patient's enrollment)
- ORR(1 year after the last patient's enrollment)
- DCR(1 year after the last patient's enrollment)
- TTR(1 year after the last patient's enrollment)
- PFS(1 year after the last patient's enrollment)
- OS-12m rate(1 year after the last patient's enrollment)
- OS(2 year after the last patient's enrollment)
研究者
Baocai Xing
Director of Surgery
Peking University Cancer Hospital & Institute
研究点 (2)
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