*Purpose: Hepatocellular carcinoma (HCC) is the 3^rd leading cause of cancer-related deaths in the world with recurrence rates at 40%. Locoregional therapy (LRT) is standard treatment to downstage or maintain lesions within Milan Criteria. Tumor resistance to LRT correlates with increased recurrence risk after transplantation. Identifying patients with aggressive tumor biology prior to intervention will help alter treatment modalities. In this study, we prospectively enrolled early stage HCC patients to determine whether liver functional reserve and tumor biomarkers prior to or during LRT follow-up were associated with treatment response and outcomes.

*Methods: Blood was collected immediately prior to LRT and within 30 days after treatment. Plasma was used to measure HCC biomarkers (α-fetoprotein (AFP), des-γ-carboxy prothrombin (DCP), and Lens culinaris agglutinin-reactive α-fetoprotein (AFP-L3)) in samples with the μTASWako i30 autoanalyzer. Tumor response to LRT was determined by mRECIST. HCC risk indices were calculated on plasma prior to LRT. Intention-to-treat (ITT) endpoint included patients that received liver transplantation or dropout due to tumor progression.

*Results: Fifty-one HCC patients were prospectively enrolled from August 2016-September 2018 with a median age of 61, 59% male, 78% were hepatitis C, and 88% within Milan criteria. A majority of patients had a complete response (44%) to LRT and remaining with partial (15%), stable (25%), or progression of disease (17%). The BALAD score, an index combining HCC biomarkers with liver functional reserve (albumin and bilirubin) was found to associate with response to LRT. Majority of patients (67%) with BALAD score ≥3 were resistant to LRT. Matched paired analysis revealed HCC biomarkers did not change regardless of response to LRT. Univariate analysis revealed all three HCC biomarkers and measurements of tumor burden (largest diameter and cumulative lesion size) were associated with tumor progression dropout. Patients stratified by BALAD score (≥3) or biomarker positivity (≥2) had significantly lower ITT surivial for tumor progression.

*Conclusions: Assessment of functional liver reserve and HCC biomarkers can predict intention-to-treat dropout prior to treatment intervention. This allows for the identification of patients with aggressive tumors that would benefit from more aggressive treatment modalities.

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