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

StatusRecruiting
PhasePhase 2
Started2024-12-02
View on ClinicalTrials.gov ↗

Amendment history

2026-07-10
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 1 site
2026-06-02
Study Status, Eligibility v14
Primary completion pushed: 2026-04 → 2027-04
Completion pushed: 2026-04 → 2027-04
Eligibility criteria-6 characters
[...] 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 les [...]
2026-02-16
Suspended→Recruiting Study Status, Contacts/Locations v13
Trial statusSuspended→Recruiting
Reason stoppedinterim analysis→not stated
Study sitesdetails revised at 1 of 1 site
2025-06-12
Recruiting→Suspended Study Status, Contacts/Locations v12
Trial statusRecruiting→Suspended
Reason stoppednot stated→interim analysis
Study sitesdetails revised at 1 of 1 site
2025-04-22
Study Status, Study Design v11
PhasePhase 1→Phase 2
Show 10 earlier versions
2025-03-04
Study Status, Eligibility v10
Eligibility criteria+55 characters
[...] lular 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, surgic [...]
2024-12-11
Study Status, Eligibility v9
Start dateestimated 2024-11→confirmed 2024-12-02
Eligibility criteria-10 characters
[...] ass A or B7 Life expectancy of 12 weeks or more At least one untreated target lesion that could be measured in one dimension, acco [...]
2024-10-10
Study Identification, Study Status, Eligibility v8
Start date2024-09→2024-11
Eligibility criteria+117 characters
[...] isease 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 t [...] e of planned study Homozygosity for UGT1A1*28 via genotyping History of liver transplant
2024-07-22
Suspended→Recruiting Study Status, Contacts/Locations v7
Trial statusSuspended→Recruiting
Reason stoppedmajor protocol revision→not stated
Start date2024-06→2024-09
Study sitesdetails revised at 1 of 1 site
2024-05-07
Recruiting→Suspended Study Status, Contacts/Locations v6
Trial statusRecruiting→Suspended
Reason stoppednot stated→major protocol revision
Start date2024-04→2024-06
Study sitesdetails revised at 1 of 1 site
2024-03-28
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2024-01→2024-04
Study sites0→1
Eligibility criteria+2 characters
[...] void pregnancy for the entire study period and for at least 820 weeksmonths after the last dose of study drug. Subjects who are pregnan [...]
Collaborators+33 characters
Sun Pharmaceutical Industries Ltd
2023-11-17
Study Status v4
Start date2023-11→2024-01
2023-09-28
Study Status v3
Start date2023-08→2023-11
2023-06-12
Study Status v2
Start date2023-05→2023-08
2023-02-22
Study Status v1
Start date2023-03→2023-05
2022-12-20
Original filing
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.
Trial Details
NCT Number NCT05669339
Lead Sponsor University of Florida
Collaborators: Sun Pharmaceutical Industries Ltd
Conditions Hepatocellular Carcinoma
Enrollment 12 participants
Start Date 2024-12-02
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-14