The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, dendritic cells activated by HBV antigen peptides and HepG2 cell protein lysate can efficiently present T cells with antigens of HCC to sensitize their antitumor properties meanwhile cyclophosphamide(CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "Activated Dendritic-cells Combined Cyclophosphamide" (ADCC) combining with TACE for patients with advanced hepatocellular carcinoma to prolong their survival time.
Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 70 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, one group (control group) will go on receiving the TACE treatment solely; another group (experimental group) after enrollment will receive TACE in the first course.Then 10ml blood is taken for activated dendritic cells culture.CY treatment will be performed on patients in reasonable dose two days before the second TACE.The day when the second TACE performed, these patients will receive activated-dendritic cells simultaneously. 31 days after the first TACE therapy, all patients are determined if they should continue an additional course by monitoring their blood parameters, tumor indicators and imaging examinations. Additionally, we are setting up a treatment course containing 31 days and going to change one course into 93 days after the third course.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Experimental groups will be given TACE as well as Activated-Dendritic Cells(1-2\*10\^8,intravenous drip),simultaneously.Cyclophosphamide(250mg/cm2,intravenous drip) will be used two days before TACE performed.
TACE solely in the first day of a clinical course.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Imaging signs
The size of tumor decrease.
Time frame: 4 years
Alpha-fetoprotein (AFP)
To decrease AFP to a low level
Time frame: 4 years
Glypican-3
To decrease Glypican-3 to a low level
Time frame: 4 years
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