A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.
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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically or histologically diagnosed HCC;
- •HCC with Vp2-Vp4 portal vein invasion;
- •intact liver function with Child-Pugh class A;
- •adequate size of RT field;
- •intact performance with ECOG below 2;
- •non-pregnant with acceptable contraception in premenopausal women);
- •without other life-threatening diseases;
- •ability to provide written informed consent and to comply with all study conditions.
排除标准
- •Active uncontrolled infection;
- •Current or history (< or = 5 years) of advanced malignancies in the other organs;
- •History of liver transplantation;
- •miliary HCC which incompatible external beam RT
研究组 & 干预措施
Therapeutic arm
AtezoBev with combined radiotherapy
干预措施: AtezoBev with combined radiotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years (per 9 weeks)
Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death
次要结局
未报告次要终点
