AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma

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 indivi

Trial Details

NCT ID
NCT05669339
Phase
PHASE2
Sponsor
University of Florida
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Irinotecan
  • Sonidegib
  • Sorafenib
Locations (sample)
  • Gainesville, Florida, United States|29.65163,-82.32483

Key Eligibility Criteria

  • Adults ≥ eighteen years of age
  • Biopsy proven advanced-stage hepatocellular carcinoma (HCC), as confirmed by pathological analysis; or confirmation of HCC from a LI-RADS 5 imaging…
  • Not eligible for, or had disease progression after, surgical or locoregional therapies when these treatments are intended as sole, definitive thera…
  • Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural hist…

For full eligibility, visit ClinicalTrials.gov.

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