AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2NCT05669339

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

A Phase 2 study testing Irinotecan, Sonidegib and Sorafenib in people with Hepatocellular Carcinoma, run by University of Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Irinotecan, Sonidegib and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
2 Dec 2024to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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:
  • Platelet count ≥ 60,000
  • Hemoglobin, ≥8.0 g/dL
  • INR ≤2.5
  • Albumin ≥2.5 g/dL
  • Total bilirubin, ≤5 mg/dL
  • ALT \& AST ≤5 times the upper limit of normal
  • Creatinine ≤ 2 times the upper limit of normal
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Latia Jackson contact

352-273-9552

latiajackson@ufl.edu

United States1 site, 1 recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Latia Jackson, 352-273-9552, latiajackson@ufl.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Irinotecan, Sonidegib, Sorafenib
Keywords
hepatocellular carcinoma, Phenotypic Personalized Medicine
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    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.

  • SonidegibDrug

    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).

  • SorafenibDrug

    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).

Study groups in NCT05669339
Study groupRoleWhat they receive
Irinotecan, Sonidegib, and SorafenibExperimentalSubjects will be assigned to a dose of each drug following a 3 + 3 design
Receives: Drug: Irinotecan; Drug: Sonidegib; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximally tolerated dose

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

    Measured: 32 days

Secondary outcomes (5)

  1. Objective response rate

    Determine the objective response rate, as measured by mRECIST 1.1 criteria

    Measured: 32 days

  2. Change in the biomarker AFP

    Measure the change in the blood level of the biomarker AFP

    Measured: 32 days

  3. Change in the biomarker AFP-L3

    Measure the change in the blood level of the biomarker AFP-L3

    Measured: 32 days

  4. Change in the biomarker DGC

    Measure the change in the blood level of the biomarker DGC

    Measured: 32 days

  5. Change in the biomarker TGF-B

    Measure the change in the blood level of the biomarker TGF-B

    Measured: 32 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start2 Dec 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669339
Sponsor's protocol ID
UF-GI-015
Other IDs
OCR43006, IRB202300226
Status last verified
Jul 2026
First submitted
20 Dec 2022
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Sonidegib and Sorafenib in people with Hepatocellular Carcinoma, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Latia Jackson (352-273-9552, latiajackson@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximally tolerated dose (time frame: 32 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in