AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
This study will test the hypothesis that a novel combination of three drugs (sorafenib,
sonidegib, and irinotecan), in conjunction with individually optimized doses, can be safely
administered and lead to improved clinical outcomes in patients with hepatocellular carcinoma
compared to standard of care. The main objective of this study is to establish safe dose
ranges for the coadministration of sorafenib, sonidegib, and irinotecan in patients with
hepatocellular carcinoma. Furthermore, we will collect data to inform the application of an
artificial intelligence/computational approach to individual dosing of combination
chemotherapy. Individualization of dosing will be achieved by using Phenotypic Personalized
Medicine (PPM) to maximize treatment efficacy in patients with hepatocellular carcinoma,
while minimizing toxicity. Drug efficacy will be assessed by measuring plasma circulating
tumor DNA (ctDNA). Toxicity will be assessed by quantitating organ injury and patient
tolerability. Recommended dosing for future studies will be based on the totality of the
data.