Yiqi (Guangxi) Medical Technology Co., Ltd.

Primary objective: Progression-free survival (PFS) in each group of the clinical trial Secondary objectives: Time to tumor progression (TTP) in each group of the clinical trial; Objective response rate (ORR) in each group of the clinical trial; Disease control rate (DCR) in each group of the clinical trial; Overall survival (OS) in each group of the clinical trial; Evaluate the safety and tolerability of the combination of YIV-906 and sorafenib based on the incidence and severity of adverse events; Changes in quality of life (QoL) in each group of the clinical trial; Determine the effect of YIV-906 on the pharmacokinetics (PK) of sorafenib. Exploratory objectives: To investigate the biological effects of YIV-906 combined with sorafenib in patients and lay the foundation for early detection, precise treatment and prognostic analysis of liver cancer, this study will analyze a series of biomarkers, including: AFP, AST, ALT, cytokines, chemokines, HBV serological markers, HBV viral load, circulating tumor DNA and serum metabolomics; analyze the correlation between the above soluble biomarker results and clinical treatment endpoints; analyze the correlation between soluble biomarkers; compare the composition of beneficial and pathogenic intestinal and oral flora between the two groups of patients, including comparisons before and after treatment.