Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA). (HCC DC CTL)

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, DC, CTL Read More

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.