An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic 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.
- •Histologically or cytologically documented hepatocellular carcinoma.
- •CNLC IIa IIb or IIIa
- •The main portal vein was not completely obstructed,
- •Child-Pugh A or B
- •At least one measurable lesion according to RECIST criteria
- •ECOG PS 0-1
- •Adequate organ function
- •Estimated life expectancy of ≥3 months
- •For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent
排除标准
- •Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
- •For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
- •The main portal vein and the left and right primary branches were clogged with cancer thrombus
- •History of hepatic encephalopathy or liver transplantation
- •Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
- •Occurred arteriovenous thromboembolic events within 6 months before the first administration.
- •Inadequately controlled hypertension.
- •Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long QT syndrome.
- •Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
- •Severe infections.
- •Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- •Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
- •Unable to receive an enhanced CT or MRI scan of the liver.
研究组 & 干预措施
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
干预措施: TACE (Procedure)
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
干预措施: AK104 (Biological)
AK104+Lenvatinib+TACE
Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 2 years
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
次要结局
- Objective response rate (ORR(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose)