RecruitingPhase 2NCT05669339

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

Sponsor

University of Florida

Enrollment

12 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence (AI) to help personalize drug dosing for patients with advanced liver cancer (hepatocellular carcinoma, or HCC). The goal is to find the right dose of treatment for each individual patient to maximize effectiveness while minimizing side effects. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced HCC confirmed by biopsy or imaging - You are not eligible for — or have already had — surgery or other local treatments intended to cure the cancer - You are willing to participate in AI-guided dosing adjustments **You may NOT be eligible if...** - You have more than one active cancer at the same time - Your liver function is severely impaired - You have serious uncontrolled infections or other major health issues - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIrinotecan

All subjects will be given either 25 mg/m2 (dose level -1), 50 mg/m2 (dose level 0), or 75 mg/m2 (dose level +1) irinotecan intravenously every 7 days.

DRUGSonidegib

All subjects will take 200 mg sonidegib orally either every 96 hours (dose level -1), every 48 hours (dose level 0), or every 24 hours (dose level +1).

DRUGSorafenib

All subjects will take 200 mg sorafenib orally either every 48 hours (dose level -1), every 24 hours (dose level 0), or every 12 hours (dose level +1).

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05669339

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