A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 724
- 试验地点
- 166
- 主要终点
- Progression Free Survival (PFS) for Arm B vs Arm C
研究概览
简要总结
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 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 to B7 and 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
- •Any history of nephrotic or nephritic syndrome
- •Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
- •Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
- •History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
- •Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
研究组 & 干预措施
Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
干预措施: Placebo (Other)
Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm C
Transarterial Chemoembolization (TACE) in combination with Placebos
干预措施: Placebo (Other)
Arm C
Transarterial Chemoembolization (TACE) in combination with Placebos
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
干预措施: Durvalumab (Drug)
Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
干预措施: Durvalumab (Drug)
Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) for Arm B vs Arm C
时间窗: Approximately 5 years
PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
次要结局
- Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)(Approximately 5 years)
- Progression Free Survival (PFS) for Arm A vs Arm C(Approximately 5 years)
- Overall Survival (OS)(Approximately 5 years)
- Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)(Approximately 5 years)