Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
Randomized, Open-label, Multi-center Clinical Trial to Compare the Efficacy and Safety of MASCT Group' and 'Non-treatment Group' in Patient Undergone Curative Resection( RFA or Operation) for Hepatocellular Carcinoma .MASCT That Expresses Multiple Antigens Specific Cellular Therapy,Autologous Immune Cytotoxic of T-lymphocytes(CTL) Induced by Dendritic Cell(DC) Loaded With Multiple Antigens
PhasePhase 1/Phase 2
Lead SponsorSYZ Cell Therapy Co..
Intervention/Treatmentmasct:multiple antigens specific cellular therapy ...
To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group' in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in China.
autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens .
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens
Inclusion Criteria: The patient is diagnosed as hepatocellular carcinoma(HCC); The patient underwent radical operation of HCC within 8 weeks before enrollment; The number of tumors≤2； No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava; No portal lymph node metastasis； No extra-hepatic metastasis; Complete tumor resection without residual tumor at the surgical margins should be confirmed by enhanced CT or MRI imaging within 4 week (including 4 weeks) after radical operation; If an increased serum AFP level was detected of the patient before the radical operation, the AFP level should be returned to normal in 8 weeks; Child-Pugh Score ≤9; ECOG Performance status (ECOG-PS) ≤2 ; The expected survival time > 2 years; Tests of blood,liver and kidney should meet the following criteria： WBC>3×109/L Neutrophil counts >1.5×109/L Hemoglobin ≥85 g/L Platelet counts≥50×109/L PT is normal or The extend time <3s BUN≤1.5 times the upper-limit , Serum creatinine≤ 1.5 times of the upper-limit Sign the informed consent. Exclusion Criteria: Women who is pregnant or during breast feeding or plan to pregnant in 2 years; Extra-hepatic metastasis or liver residual tumor; Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava; 6 months before enrollment: the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) was longer than 3 months; 6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months; Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment; Positive for HIV antibody or HCV antibody; Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1); Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma); . Patients with organ failure; Patients with serious mental disease; Drug addiction in 1year before enrollment (including alcoholics); Participated in other clinical trials in 3 months before screening; Other reasons the researchers think not suitable.