2023-509053-32-00招募中3 期
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
- 招募中
- 入组人数
- 76
- 试验地点
- 17
- 主要终点
- Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
研究概览
简要总结
To assess the efficacy of durvalumab and bevacizumab when given with transarterial chemoembolization (TACE) compared to TACE + placebo
研究设计
- 分配方式
- Randomized
- 主要目的
- Na
- 盲法
- Double (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 mRECIST criteria. Adequate organ and marrow function.
排除标准
- •Any history of nephrotic or nephritic syndrome. Clinically significant cardiovascular disease or arterial thrombotic event, including 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, or active GI bleeding within 6 months prior to enrollment. Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded.
结局指标
主要结局
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
次要结局
- Overall Survival (OS). Objective Response Rate (ORR). Disease Control Rate (DCR). Duration of Response (DoR). Time to progression (TTP). Time from Randomization to Second Progression PFS (PFS2). Health-related quality of life (HRQoL) patient reported outcomes.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (17)
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