Actively Recruiting
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
Led by University of Florida · Updated on 2026-02-18
12
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
S
Sun Pharmaceutical Industries Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Biopsy proven advanced-stage hepatocellular carcinoma or confirmed by LI-RADS 5 imaging score
- Not eligible for or progressed after surgical or locoregional therapies intended as sole curative treatment
- No more than one active malignancy at enrollment unless deemed not interfering by physician
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Child-Pugh liver function class A or B7
- Life expectancy of at least 12 weeks
- At least one measurable target lesion per mRECIST criteria
- Laboratory values meeting specified thresholds for platelets, hemoglobin, INR, albumin, bilirubin, ALT, AST, and creatinine
- Written informed consent and agreement to comply with study procedures
- Use of adequate contraception for subjects of childbearing potential during study and for 20 months after last dose
- Partners of childbearing potential must use approved contraception for study duration and 8 months after last dose
You will not qualify if you...
- Subjects of childbearing potential unwilling or unable to use acceptable contraception during study and for 20 months after last dose
- Pregnant or breastfeeding individuals
- Any disease or condition that contraindicates protocol therapy or affects study results as judged by physician
- Prisoners or involuntarily incarcerated individuals
- Inability to follow up with treatment center for up to 12 weeks after enrollment
- Planned major surgery during study period
- Homozygosity for UGT1A1*28 genotype
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
J
Jessica Ross
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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