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临床试验/NCT07091942
NCT07091942招募中不适用

Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma: A Multinational Retrospective Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2025年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
1
主要终点
Recurrence-free survival

研究概览

简要总结

Combination immunotherapy is currently the standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Approximately 30 % of patients treated with atezolizumab plus bevacizumab (Atezo-Bev) achieve complete or partial tumor response. Some patients who reach a partial response experience enough tumor regression to undergo curative therapies and subsequently attain a disease-free state. However, whether the prognosis of patients who become disease-free after curative therapy equals that of patients who achieve complete response with Atezo-Bev alone is unclear. Likewise, it remains uncertain whether patients who achieve partial response with Atezo-Bev and later undergo curative therapy fare better than those who remain in partial response without further curative treatment. Therefore, we designed this multinational, multicenter, retrospective chart-review study to address these questions.

Planned Cohorts

  • Curative-therapy cohort: Patients with unresectable HCC who achieve partial response to Atezo-Bev and subsequently receive curative therapy-surgical resection, radiofrequency ablation, or definitive radiotherapy-to achieve a disease-free state.
  • Control cohort: Patients with unresectable HCC who achieve complete or partial response to Atezo-Bev but do not undergo subsequent curative therapy.

Methods and End-points Data will be collected from no more than 30 hospitals worldwide, targeting roughly 400 patients in the curative-therapy cohort and 1,200 patients in the control cohort. Medical-record review will gather baseline characteristics, disease status, liver function, Atezo-Bev treatment details, curative-therapy specifics, treatment responses, and survival outcomes. The primary objective is to compare recurrence-free survival between the two cohorts. This retrospective study will close data collection on 31 March 2025.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Histologically or clinically (the presence of liver cirrhosis and typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
  • Received Atezo-Bev containing treatment as first-line systemic therapy for HCC
  • Patients with or without macrovascular invasion and main portal vein invasion before Atezo-Bev containing treatment can be enrolled
  • Patients with or without extrahepatic spread before Atezo-Bev containing treatment can be enrolled
  • Obtained CR or PR, according to RECIST version 1.1, to Atezo-Bev treatment

排除标准

  • Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  • Received anti-CTLA4 antibodies simultaneously with Atezo-Bev Patients who received Atezo-Bev in combination with investigational drugs such as tiragolumab, relatlimab, and tocilizumab were allowed to enter the study.
  • Received locoregional therapy simultaneously with Atezo-Bev treatment, such as transarterial chemoembolization (TACE), hepatic arterial infusion of chemotherapy (HAIC), transarterial radioembolization, radiofrequency ablation, and microwave ablation before obtaining PR or not for curative intent

结局指标

主要结局

Recurrence-free survival

时间窗: From initiation of atezolizumab-bevacizumab treatment to disease recurrence or date of death from any cause, whichever came first, assessed up to 8 years

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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