A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: MG4101
- Registration Number
- NCT02854839
- Lead Sponsor
- GC Cell Corporation
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The Treatment Group (MG4101) MG4101 Patients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7.
- Primary Outcome Measures
Name Time Method Time To progression every 12 weeks, up to the time of death or 18 months
- Secondary Outcome Measures
Name Time Method Safety of MG4101 as evaluated by Incidence of adverse events (AEs), serious adverse events (SAEs) up tp 9 weeks Overall survival every 12 weeks, up to the time of death, up to 18 months Progression-free survival every 12 weeks, up to the time of death or tumor progression, up to 18 months change of Tumor Markers(AFP, Alpha-Fetoprotein) every 12 weeks, up to the time of death or tumor progression, up to 18 months
Trial Locations
- Locations (6)
Ajou Univ. Hospital
🇰🇷Suwon, Korea, Republic of
Severance hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea Univ. Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Asan Medical center
🇰🇷Seoul, Korea, Republic of