NCT02856815

Safety and Efficacy of "Immuncell-LC" in TACE Therapy

Randomized, Open-label, Multi-center and Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in the Patients Undergone TACE for Intermediate Stage Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: GC Cell Corporation · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma

Detailed description

ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary outcome, recurrence free survival(RFS) will be evaluated. For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and hematological examination will be evaluated.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
BIOLOGICAL	Immuncell-LC	Activated T lymphocyte : intravenous dripping of 200ml (1 x 10\^9 \~ 2 x 10\^10 lymphocytes / 60kg adult) for 1 hour

Timeline

• Start date: 2018-05-28
• Primary completion: 2020-08-11
• Completion: 2022-09-22
• First posted: 2016-08-05
• Last updated: 2023-06-22

Locations

3 sites across 1 country: South Korea