NCT02232490

Liver Cancer Immunotherapy: Placebo-controlled Clinical Trial of Hepcortespenlisimut-L

Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Immunitor LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.

Detailed description

Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.

Conditions

• Hepatocellular Carcinoma
• HCC
• Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	hepcortespenlisimut-L	hepcortespenlisimut-L (V5) is given in experimental arm
BIOLOGICAL	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2014-09-05
• Last updated: 2019-02-26

Locations

2 sites across 1 country: Mongolia