Clinical Drug Experience Knowledgebase

Criteria

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.