Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study adopted a bidirectional cohort study design. On the one hand, the previous clinical data, treatment exposure and clinical endpoint events of the enrolled patients were retrospectively collected. On the other hand, prospective regular follow-up was conducted from the date of enrollment to continuously observe long-term recurrence, progression and survival outcomes, and analyze the correlation between related factors and prognosis. The primary objective of this study was to describe the efficacy and safety of SIRT-Y90 in combination with atezolizumab and bevacizumab in adult patients with unresectable HCC in China. Medical records from approximately eight sites in China will be used.
详细描述
Inclusion criteria:
Age ≥18 years old A diagnosis of unresectable HCC was made. HCC can be diagnosed clinically or pathologically.
At least one Atezo plus Bev administration and one cycle of SIRT-Y90 treatment. At least one visit was recorded after the initiation of Atezo + Bev and SIRT-Y90
Exclusion criteria:
Concomitant cancers other than BCC were diagnosed before or at the start of Atezo + Bev or SIRT-Y90 Participate in an interventional clinical study before or at the time of initiation of treatment with Atezo + Bev or SIRT-Y90 Primary endpoint Objective response rate: defined as the percentage of patients who had a complete response (CR) or partial response (PR) at the follow-up date. If multiple response assessments were available within that time frame, the best overall response (BOR) was applied. Both RECIST 1.1 and mRECIST will be used to assess tumor response Solution. Secondary Endpoints Progression-Free Survival(PFS): Defined as the time from the index date to disease progression or death from any cause, whichever occurs first. Patients with unknown progression or death will be right-censored at the end of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old A diagnosis of unresectable HCC was made. HCC can be diagnosed clinically or pathologically.
- •At least one Atezo plus Bev administration and one cycle of SIRT-Y90 treatment. At least one visit was recorded after the initiation of Atezo + Bev and SIRT-Y90
排除标准
- •Concomitant cancers other than BCC were diagnosed before or at the start of Atezo + Bev or SIRT-Y90 Participate in an interventional clinical study before or at the time of initiation of treatment with Atezo + Bev or SIRT-Y90
研究者
Guohong Han
Doctor
Air Force Military Medical University, China