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Hepcortespenlisimut-L (V5) in advanced HCC
NCT02256514Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 2014
- Primary completion
- Sep 2019
- Countries
- 1
- Sponsor
- Immunitor Inc.
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of hepcortespenlisimut-l in hepatocellular carcinoma (HCC), sponsored by Immunitor Inc. Primary endpoints: Serum Alpha-fetoprotein Levels at 3 months and Tumor Size or Clearance at 3 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Daily oral dose of hepcortespenlisimut-L
Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day
03
Who it enrols
Adult patients with advanced or recurrent HCC not amenable to surgery, with AFP >= 30 IU/ml. Excludes pregnant women, active substance abuse, and recent use of other immunomodulators.
04
Endpoints
Primary
Serum Alpha-fetoprotein Levels
Tumor Size or Clearance
Secondary
Blood Biochemistry Parameters
Patients' Performance
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