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Drug Combination for Liver Cancer

Phase 1
Recruiting
Led By Ali Zarrinpar, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 days
Awards & highlights

Summary

This trial aims to test a new combination of three drugs for treating liver cancer. The study will determine safe doses of the drugs and evaluate their effectiveness in improving patient outcomes compared to the current standard treatment.

Who is the study for?
Adults over 18 with advanced-stage liver cancer (HCC) confirmed by biopsy, who can't have or haven't improved with surgery or local treatments. They should be relatively active (ECOG ≤2), have a life expectancy of at least 12 weeks, and not be dealing with other serious cancers. Their liver must still work fairly well (Child-Pugh A or B7), and they need to have at least one measurable tumor that hasn’t been treated.
What is being tested?
The trial is testing a new combination of three drugs: sorafenib, sonidegib, and irinotecan. It aims to find safe doses for these drugs when used together in liver cancer patients. The study will use AI to personalize drug dosing for each patient to maximize benefits while reducing side effects. Success will be measured by looking at changes in ctDNA levels in the blood and how well patients tolerate treatment.
What are the potential side effects?
Possible side effects include damage to organs due to toxicity from the medications, which could affect how well they function. Patients might also experience general discomforts like nausea or fatigue as their bodies react to the drug combination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximally tolerated dose
Secondary study objectives
Change in the biomarker AFP
Change in the biomarker AFP-L3
Change in the biomarker DGC
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Irinotecan, Sonidegib, and SorafenibExperimental Treatment3 Interventions
Subjects will be assigned to a dose of each drug following a 3 + 3 design
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sonidegib
2014
Completed Phase 2
~100
Irinotecan
2017
Completed Phase 3
~2580
Sorafenib
2014
Completed Phase 3
~1670

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LtdUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,383 Total Patients Enrolled
1 Trials studying Liver Cancer
41 Patients Enrolled for Liver Cancer
Ali Zarrinpar, MD, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
67 Total Patients Enrolled
~8 spots leftby Apr 2026
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