Phase
Condition
Liver Cancer
Cancer/tumors
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages 20-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 firstbranch, 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 beconfirmed by enhanced CT or MRI imaging within 4 week (including 4 weeks) afterradical operation;
If an increased serum AFP level was detected of the patient before the radicaloperation, 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
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 firstbranch, hepatic vein, inferior vena cava;
6 months before enrollment: the period of systemic and continuous use ofimmunomodulatory 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 theimmunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 monthsbefore enrollment;
Positive for HIV antibody or HCV antibody;
Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoidarthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
Patient who suffered from other malignant tumor in 5 years before enrollment (exceptskin 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.
Study Design
Connect with a study center
JOE ZHOU
Shenzhen, Guangdong 518006
ChinaSite Not Available

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