Spots Global Cancer Trial Database for Safety and Efficacy of "Immuncell-LC" in TACE Therapy
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Trial Identification
Brief Title: Safety and Efficacy of "Immuncell-LC" in TACE Therapy
Official Title: 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
Study ID: NCT02856815
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Seoul St.Mary's Hospital, Seoul, Banpo-daero 222 / Seocho-go, Korea, Republic of
Seoul National University Hospital, Seoul, Daehak-ro 101/Jongno-gu, Korea, Republic of
Severance Hospital, Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, Korea, Republic of
Contact Details
Name: Jung Hwan Yoon, MD
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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