The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?
Study Type
OBSERVATIONAL
Enrollment
400
Including regimens such as Atezolizumab + Bevacizumab, Nivolumab + Ipilimumab.
Including therapy such as TACE, HAIC
Objective Response Rate (ORR) Assessed by RECIST v1.1 and HCC mRECIST Criteria
The ORR will be evaluated according to RECIST v1.1 and HCC mRECIST criteria, defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.
Time frame: Up to 2 years (assessed every 8 ± 2 weeks)
Levels of Predictive Biomarkers Assessed by Multi-Omics Sequencing and Single Cell RNA Sequencing
Identify 3-4 predictive biomarkers for the efficacy of HCC systemic therapy, including genes, proteins, ctDNA, and immune cell subsets based on tumor tissue or peripheral blood.
Time frame: Up to 2 years
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