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Cancer Vaccine

NP-101 for Liver Cancer

Phase 1
Waitlist Available
Led By Ilyas Sahin, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable HCC or not eligible for surgical resection or liver transplantation
Adults ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study a new drug, NP-101, derived from black seed, for patients with advanced liver cancer who cannot undergo surgery or transplantation. The drug has shown immune-modulating and anti

Who is the study for?
This trial is for adults over 18 with unresectable hepatocellular carcinoma (HCC) who can't have surgery or a liver transplant. They must be in good physical condition, have certain blood cell counts within range, and agree to provide tissue samples for research.
What is being tested?
The study tests different doses of NP-101, an immune-modulating drug derived from black seed, in patients with HCC undergoing Y-90 treatment. It aims to find the highest dose that doesn't cause too many side effects (maximum tolerated dose).
What are the potential side effects?
Possible side effects are not detailed here but will relate to the drug's impact on the immune system and its ability to modulate it. The study specifically looks out for any dose-limiting toxicities as a measure of safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver cancer cannot be removed by surgery or treated with a liver transplant.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am willing to have biopsies before and after treatment for research.
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My liver function is classified as good to moderate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose
Secondary study objectives
Disease control rate
Duration of response
Overall response rate
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: NP-101 (6 g)Experimental Treatment1 Intervention
Group II: NP-101 (4.8 g)Experimental Treatment1 Intervention
Group III: NP-101 (3 g)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Florida Department of HealthOTHER_GOV
29 Previous Clinical Trials
13,011 Total Patients Enrolled
University of FloridaLead Sponsor
1,400 Previous Clinical Trials
767,091 Total Patients Enrolled
1 Trials studying Liver Cancer
41 Patients Enrolled for Liver Cancer
NovatekUNKNOWN
~12 spots leftby Jul 2026
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