Clinical trials for hepatocellular carcinoma: are we reaching the most vulnerable patients?

Hepatocellular carcinoma (HCC) is more common in vulnerable populations, but the impact of social vulnerability on clinical trial participation remains unclear.

Adults with a diagnosis of HCC between 2019 and 2023 in the United States-based Vizient Clinical Database were analyzed. Univariate and multivariable analyses evaluated the association between the Vizient Vulnerability Index (VVI), a census track level measure of social vulnerability, and clinical trial participation. Interaction tests were performed for race/ethnicity and VVI.

Among 201,704 HCC patients, 2.1% participated in a clinical trial. Participants were more often White (57% vs 53%), commercially insured (27% vs 22%), had MELD-Na<10 (10% vs 5%), and metabolic liver disease (28% vs 18%), all p < 0.0001. Lower odds of enrollment were observed in patients identifying as Black (OR 0.80) or Hispanic (OR 0.82), on Medicaid (OR 0.69), receiving care at a community hospital (OR 0.41), and residing in the most vulnerable census tracts (OR 0.87); all p < 0.001. High social vulnerability in healthcare access, neighborhood resources, and transportation was associated with lower participation (all p < 0.0001).

HCC patients who live in socially vulnerable communities are less likely to participate in clinical trials. Social vulnerability has a disproportionate impact on trial enrollment for Black and Hispanic patients.