Health TrialsbyHealthPanel

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

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Florida

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Irinotecan

    Drug

    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.

  • Sonidegib

    Drug

    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).

  • Sorafenib

    Drug

    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).

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Irinotecan, Sonidegib, and SorafenibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Maximally tolerated dose

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

Time frame
32 days

Secondary outcomes

1

Objective response rate

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

Time frame
32 days
2

Change in the biomarker AFP

Measure the change in the blood level of the biomarker AFP

Time frame
32 days
3

Change in the biomarker AFP-L3

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

Time frame
32 days
4

Change in the biomarker DGC

Measure the change in the blood level of the biomarker DGC

Time frame
32 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Sun Pharmaceutical Industries Ltd

Collaborator

Source ClinicalTrials.gov
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