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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
The first cycle (3 weeks) receives bevacizumab monotherapy, and from the second cycle onwards, it is combined with atezolizumab until disease progression or intolerable toxicity.
Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGobjective response rate (ORR)
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.
Time frame: 6 Months
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