OncoMatch/Clinical Trials/NCT05669339
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
Is NCT05669339 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Irinotecan and Sonidegib for hepatocellular carcinoma.
Treatment: Irinotecan · Sonidegib · Sorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Excluded: UGT1A1 *28 homozygosity
Homozygosity for UGT1A1*28 via genotyping
Disease stage
Required: Stage ADVANCED-STAGE
Biopsy proven advanced-stage hepatocellular carcinoma (HCC), as confirmed by pathological analysis; or confirmation of HCC from a LI-RADS 5 imaging score.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Platelet count ≥ 60,000; Hemoglobin ≥8.0 g/dL; INR ≤2.5
Kidney function
Creatinine ≤ 2 times the upper limit of normal
Liver function
Child-Pugh liver function class A or B7; Albumin ≥2.5 g/dL; Total bilirubin ≤5 mg/dL; ALT & AST ≤5 times the upper limit of normal
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; Child-Pugh liver function class A or B7
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
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