A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score: The UCGI 41 HESTIA TRIAL DESIGN AND PRELIMINARY SAFETY Data.
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BACKGROUND: Hepatocellular carcinoma (HCC) frequently develops in underlying cirrhosis. Liver dysfunction impacts survival and may influence treatment results. About a quarter of patients with advanced HCC present with Child-Pugh B liver functions. All recent phase 3 trials validating standard of care limited inclusion to patients with Child-Pugh A liver function. Results of immunotherapy is less described in patients with altered liver function. We previously showed that the ALBI grade might be able to better select patients with Child-Pugh B liver functions who could benefit from sorafenib. Single-agent anti-PD-(L)1 antibodies might have a more favorable safety profile than standard of care combinations. METHODS: We thus launched a study, the HESTIA trial, testing tislelizumab, an anti-PD-1 antibody that was demonstrated as non-inferior to sorafenib as first-line treatment, in the population of patients with advanced HCC, Child-Pugh B and ALBI grade 1 or 2 liver function. RESULTS: In this article, we present the design of the study and first safety results. This is a single-arm phase 2 study. Fifty patients will be included. The primary endpoint is objective response rate. The first safety analysis showed no signal of increased toxicity of the drugs. However, this population is at high risk for liver-related adverse events. CONCLUSION: The study is currently pursuing accrual.