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临床试验/NCT05908916
NCT05908916尚未招募2 期

A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Yonsei University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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