Effectiveness and Safety of Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization as Conversion Therapy Among Patients With Initially Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 5
- 主要终点
- Median Time to Real-World Progression-Free Survival (rwPFS)
研究概览
简要总结
This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Eligible patients diagnosed with unresectable HCC initiating the Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 will be included in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •No visit record after initiating both Atezo+Bev and TACE
- •Treated with other systemic therapy or resection against HCC
- •Diagnosed with concomitant cancer except for basal cell carcinoma
- •Advanced portal vein tumor thrombosis (PVTT) as defined by: Grade Vp 4, Cheng's Classification Type III or IV, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein
- •China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis
- •Terminal-stage HCC
研究组 & 干预措施
Retrospective Cohort
Secondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.
干预措施: Atezolizumab (Drug)
Retrospective Cohort
Secondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.
干预措施: Bevacizumab (Drug)
Retrospective Cohort
Secondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.
干预措施: Transarterial Chemoembolization (Radiation)
结局指标
主要结局
Median Time to Real-World Progression-Free Survival (rwPFS)
时间窗: up to approximately 12 months
rwPFS is defined as time from the index date to the first evidence of clinician-assessed progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause.
次要结局
- Median Time to Real-World Overall Survival (rwOS)(up to approximately 3 years)
- Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction(up to approximately 4 years)
- Median Time to Real-World Overall Response Rate (rwORR)(up to approximately 3 years)
- Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction:(up to approximately 4 years)
- Percentage of Participants with Surgical Resection(up to approximately 4 years)
- Percentage of Participants with Adverse Events(up to approximately 4 years)