The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in: 1. Reduction of tumor size 2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions. 60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tri Service General Hospital
Taipei, Taiwan
RECRUITINGChange of tumor size
Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes
Time frame: One year
Progression-Free Survival (PFS)
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse
Time frame: One year
Improvement of immune responses
Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses
Time frame: One year
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