Back to search results

AI-Based Drug Dosing for Hepatocellular Carcinoma

This study is looking at a new way to treat hepatocellular carcinoma (a type of liver cancer) using a combination of three drugs: irinotecan, sonidegib, and sorafenib. The goal is to find the safest and most effective doses of these drugs when given together, potentially using artificial intelligence to personalize the treatment. You might be able to join if you are an adult (18-99 years old) with advanced-stage hepatocellular carcinoma that has been confirmed by a biopsy or imaging. The main measure of success for this study is finding the highest dose of the drugs that can be given safely over 32 days. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is testing different dose levels of three drugs.
What's involved
You would receive irinotecan intravenously every 7 days, and take sonidegib and sorafenib orally at different frequencies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, maximally tolerated dose, is measured at 32 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05669339

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

Recruiting
PHASE2Ages 18–99InterventionalTreatment
University of Florida
~12 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:IrinotecanSonidegibSorafenib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximally tolerated dose
Measured over 32 days

Conditions

Hepatocellular Carcinoma

Explore related trials

Hepatocellular Carcinoma

NCT05669339

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Florida

    Gainesville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ali Zarrinpar, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Latia Jackson
[email protected]
352-273-9552
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 score.
Not eligible for, or had disease progression after, surgical or locoregional therapies when these treatments are intended as sole, definitive therapy aimed at curing the disease, rather than as part of a combination therapy approach
Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included).
Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
Child-Pugh liver function class A
Life expectancy of 12 weeks or more
At least one target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (mRECIST).
Must have lab values consistent with the following:
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 20 months after the last dose of study drug to minimize the risk of pregnancy.
Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 8 months following the last dose of study drug.

Exclusion

Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 20 months after the last dose of study drug.
Subjects who are pregnant or breastfeeding.
History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications or protocol noncompliance, in the opinion of the treating physician.
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Inability to follow up with treatment center for up to 12 weeks after enrollment
Anticipated major surgery during the time of planned study
Homozygosity for UGT1A1\*28 via genotyping

What this trial measures

  • Maximally tolerated dose32 days

    Determine the maximum tolerated dose of irinotecan, sonidegib, and sorafenib