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

BACKGROUND

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

METHODS

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.

RESULTS

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).

CONCLUSION

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.