Hepatocellular Carcinoma
Conditions
Keywords
HCC, DC, CTL
Brief summary
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.
Interventions
BIOLOGICALMASCT:Multiple Antigens Specific Cellular Therapy
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 .
OTHERThe foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Sponsors
Nanfang Hospital, Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Beijing 302 Hospital
Fujian Cancer Hospital
HRYZ Biotech Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is diagnosed as hepatocellular carcinoma(HCC); 2. The patient underwent radical operation of HCC within 8 weeks before enrollment; 3. The number of tumors≤2； 4. No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava; 5. No portal lymph node metastasis； 6. No extra-hepatic metastasis; 7. 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; 8. 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; 9. Child-Pugh Score ≤9; 10. ECOG Performance status (ECOG-PS) ≤2 ; 11. The expected survival time \> 2 years; 12. 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 13. Sign the informed consent.
Exclusion criteria
1. Women who is pregnant or during breast feeding or plan to pregnant in 2 years; 2. Extra-hepatic metastasis or liver residual tumor; 3. Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava; 4. 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; 5. 6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months; 6. Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment; 7. Positive for HIV antibody or HCV antibody; 8. Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1); 9. Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma); 10. . Patients with organ failure; 11. Patients with serious mental disease; 12. Drug addiction in 1year before enrollment (including alcoholics); 13. Participated in other clinical trials in 3 months before screening; 14. Other reasons the researchers think not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with tumor recurrence or metastasis | 5years |
| Time of tumor recurrence or metastasis | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis B virus markers figures | an expected average of 18 weeks |
| Serum hepatitis B virus (HBV)DNA figures | an expected average of 16 weeks |
| overall survival | 5 years |
Countries
China
Outcome results
None listed