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

Inclusion Criteria:

• Adults ≥ eighteen years of age

• Biopsy proven advanced-stage hepatocellular carcinoma (HCC), as confirmed bypathological analysis; or confirmation of HCC from a LI-RADS 5 imaging score.

• Not eligible for, or had disease progression after, surgical or locoregionaltherapies when these treatments are intended as sole, definitive therapy aimed atcuring 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 treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen [as determined by the treating physician and approved bythe PI] may be included).

• Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

• Child-Pugh liver function class A or B7

• Life expectancy of 12 weeks or more

• At least one target lesion that could be measured in one dimension, according to theResponse Evaluation Criteria in Solid Tumors (mRECIST).

• Must have lab values consistent with the following:

1. Platelet count ≥ 60,000

2. Hemoglobin, ≥8.0 g/dL

3. INR ≤2.5

4. Albumin ≥2.5 g/dL

5. Total bilirubin, ≤5 mg/dL

6. ALT & AST ≤5 times the upper limit of normal

7. Creatinine ≤ 2 times the upper limit of normal

• Written informed consent obtained from the subject and the subject agrees to complywith all the study-related procedures.

• Subjects of childbearing potential (SOCBP) must be using an adequate method ofcontraception to avoid pregnancy throughout the study and for at least 20 monthsafter the last dose of study drug to minimize the risk of pregnancy.

• Subjects with partners of child-bearing potential must agree to usephysician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)throughout the study and should avoid conceiving children for 8 months following thelast dose of study drug.

Exclusion Criteria:

• Subjects of childbearing potential who are unwilling or unable to use an acceptablemethod to avoid pregnancy for the entire study period and for at least 20 monthsafter 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 conditionthat contraindicates the use of protocol therapy or that might affect theinterpretation of the results of the study or that puts the subject at high risk fortreatment complications or protocol noncompliance, in the opinion of the treatingphysician.

• Prisoners or subjects who are involuntarily incarcerated, or subjects who arecompulsorily 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