2023-507689-26-00招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 33
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
To assess the efficacy of durvalumab in combination with bevacizumab compared to placebo in terms of Recurrence-free survival (RFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Subjects that completed/discontinued treatment
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •1.Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation) 2.Imaging to confirm disease-free status within 28 days prior to randomization 3.ECOG 0-1 at enrolment 4.Child-Pugh score of 5 or 6 5.Patients with HBV infection must receive antiviral therapy at least after enrollment per institutional practice to ensure adequate viral suppression prior to randomization. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. 6.Patients with HCV infection must be managed per local institutional practice for the study. 7.Adequate organ and marrow function, as defined by the CSP
排除标准
- •1.Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2.Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging. 3.History of hepatic encephalopathy within 12 months prior to randomization 4.Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging 5.Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded. 6.Active co-infection with HBV and HDV. 7.Receipt of prior systemic anticancer therapy for HCC 8.Those on a waiting list for liver transplantation
结局指标
主要结局
Recurrence-free survival (RFS)
Recurrence-free survival (RFS)
次要结局
- Overall survival (OS) Time to recurrence (TTR) RFS at 24 months (RFS24) and RFS at 36 months (RFS36) Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (33)
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