Safety and Efficacy Study of Mix Vaccine in Hepatocyte Carcinoma Patient

Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Hepatocyte Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression. Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Patients in this group will be receiving standard treatment according to National Comprehensive Cancer Network (NCCN) guide line

Patients in this group will be receiving both standard treatment according to NCCN guide line and simultaneous injection of mix vaccine (MV)

MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1

Inclusion Criteria: Patients diagnosed with hepatocyte carcinoma based on histology Evaluable lesions on imaging study Without known immunodeficiency Age >18 and <80 years ago Exclusion Criteria: Patients is unable or unwilling to sign informed consent Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication Positive HIV and/or RPR (rapid plasma reagin) Female patient who is pregnant or breast feeding Patients, based on the opinion pf the investigator, should not be enrolled into this study Prior anti-cancer vaccine or biological immunotherapy Allergic to any known ingredient of the MV compound