Last updated on January 2017

A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma


Brief description of study

The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).

Detailed Study Description

This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group). Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient`s enrollment date. The Control group`s patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient`s enrollment date.

Clinical Study Identifier: NCT02854839

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Jung-Hwan Yoon, MD, PHD

Seoul National University Hospital
Seoul, Korea, Republic of
  Connect »

Kyung gue Lee

Seoul Asan Medical center
Seoul, Korea, Republic of
  Connect »

Joon Hyeok Lee, MD, PhD

Samsung Medical Center
Seoul, Korea, Republic of
  Connect »