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临床试验/NCT07285850
NCT07285850招募中2 期

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月20日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
1
主要终点
objective response rate (ORR)

研究概览

简要总结

This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.

详细描述

The study will recruit 20 patients, randomly dividing them into sequential and concurrent groups for up to 6 months of treatment and follow-up. In addition to routine efficacy assessments, the study will analyze changes in the microenvironment before and after treatment, including T-cell calcium levels, VEGFA expression, and immune-related factor alterations. Furthermore, it will explore the relationship between T-cell calcium signaling genes and treatment response, evaluating the impact of baseline metabolic characteristics (such as blood lipids and insulin resistance) on therapeutic outcomes.

In terms of safety, the study will monitor all adverse events (AEs) and serious adverse events (SAEs), and classify them according to the CTCAE 5.0 criteria. During the treatment period, patients will undergo regular liver biopsy to assess changes in the tumor microenvironment. The ultimate goal of the study is to provide evidence-based precision treatment strategies for MASLD-HCC patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

Experimental

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

干预措施: Sequential treatment of bevacizumab combined with atezolizumab (sequential group) (Drug)

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Active Comparator

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

干预措施: Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) (Drug)

结局指标

主要结局

objective response rate (ORR)

时间窗: 6 Months

Compare the objective response rate (ORR) of sequential treatment with bevacizumab combined with atezolizumab (sequential group) and concurrent treatment (concurrent group) in advanced HCC under MASLD background, according to RECIST 1.1 criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shen Feng

Director of Clinical Research Institute

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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