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Brief Title: Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
Official Title: A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
Study ID: NCT03592706
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tri Service General Hospital, Taipei, , Taiwan
Name: Chung-Bao Hsieh, MD
Affiliation: Tri-Service General Hospital
Role: PRINCIPAL_INVESTIGATOR