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About
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).
Full 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria
Patients who are between 20 to 80 years of age
Life expectancy > 12 weeks
Patients have complete remission according to the mRECIST by Dynamic contrast-enhanced 3- or 4-phase CT or tissue biopsy
Previous TACE with the following:
Patients who had local treatment such as Resection, Radiofrequency Ablation, Percutaneous ethanol injection and Transarterial chemoembolization can participates study.
Patients whose Child-Pugh score is less than B8.
Patients whose ECOG score is 0
Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test.
Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion criteria
Patients who have metastasis.
Patients who have Portal vein or hepatic vein invasion.
Patient with medical history for the following:
Patients who have a history of malignant tumors in 5 years prior to the study with the exception of Carcinoma in situ..
Patients who have a history of autoimmune disease such as Rheuma-toid arthritis, systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-dependent Diabetes Mellitus, etc.
Patients who have history of human immunodeficiency virus (HIV) infection.
Patients who have participated in other clinical trials within 4 weeks prior to this study.
Patients who treated with immunosuppressant for 3 months prior to this study.
Patients who have any condition that was uncontrolled or needed treatment.
Pregnant or breast-feeding subjects.
Primary purpose
Allocation
Interventional model
Masking
78 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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