A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 760
- 试验地点
- 172
- 主要终点
- Progression Free Survival (PFS) for Arm A vs Arm C
研究概览
简要总结
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
详细描述
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No evidence of extrahepatic disease
- •Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
- •Child Pugh score class A
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- •Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
- •Adequate organ and marrow function
排除标准
- •History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
- •History of hepatic encephalopathy
- •Major portal vein thrombosis visible on baseline imaging
- •Uncontrolled arterial hypertension
- •Co-infection with HBV and HDV
研究组 & 干预措施
Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
干预措施: Durvalumab (Drug)
Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm C
Transarterial Chemoembolization (TACE)
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
干预措施: Tremelimumab (Drug)
Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
干预措施: Lenvatinib (Drug)
Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
干预措施: Tremelimumab (Drug)
Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
干预措施: Durvalumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) for Arm A vs Arm C
时间窗: Approximately 5 years
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
次要结局
- Overall Survival (OS) for Arm B vs Arm C(Approximately 5 years)
- Overall Survival (OS) for Arm A vs Arm C(Approximately 5 years)
- Progression Free Survival (PFS) for Arm B vs Arm C(Approximately 5 years)