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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 99 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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:
• 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.

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

sorafenib tosylate. The tosylate salt of sorafenib, a synthetic compound targeting growth signaling and angiogenesis. Sorafenib blocks the enzyme RAF kinase, a critical component of the RAF/MEK/ERK signaling pathway that controls cell division and proliferation; in addition, sorafenib inhibits the VEGFR-2/PDGFR-beta signaling cascade, thereby blocking tumor angiogenesis. NCI Drug Dictionary

sonidegib. An orally bioavailable small-molecule smoothened (Smo) antagonist with potential antineoplastic activity. Sonidegib selectively binds to the hedgehog (Hh)-ligand cell surface receptor Smo, which may result in the suppression of the Hh signaling pathway and, so, the inhibition of tumor cells in which this pathway is abnormally activated. The Hh signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular proliferation, as is observed in a variety of cancers, may be associated with mutations in the Hh-ligand cell surface receptor Smo. NCI Drug Dictionary

irinotecan hydrochloride. The hydrochloride salt of a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent. NCI Drug Dictionary

Treatments listed in the registry

• 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).

Na · Sequential · masking: None

Main goals

• Maximally tolerated dose (32 days)

Other goals

• Objective response rate
• Change in the biomarker AFP
• Change in the biomarker AFP-L3
• Change in the biomarker DGC
• Change in the biomarker TGF-B

Planned enrollment: 12 (estimated).

• University of Florida, Gainesville, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05669339
• NCI Drug Dictionary: C2194
• NCI Drug Dictionary: C82385
• NCI Drug Dictionary: C1381

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 13, 2026. Public record; not medical advice.