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, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.
Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, control group will receive radical surgery or TACE or targeted agent treatment solely; another group (experimental group) after enrollment will radical surgery or TACE or targeted agent treatment in the first course. Then 20ml blood is taken for multiple signals loaded dendritic cells (MSDCV) culture (cell culture takes 7 days). Low dose (250mg/m\^2) CY treatment will be performed on patients two days before the MSDCV treatment. The MSDCV combined CY therapy will perform per 4 weeks, total 6 times. All patients are evaluated the safety and efficacy of treatment by monitoring their blood parameters, tumor indicators and imaging examinations at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Intravenous drip,250mg/m\^2 per time,two days before each times of MSDCV therapy,total 6 times, in order to improve the immunosuppressive microenvironment of tumor,reduce CD4+CD25+FOXP3+regulatory T cells (Tregs)
one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;
Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Third Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
RECRUITINGProgression-Free-Survival (PFS), month
The time from randomization until first documented progression or death from any cause,whichever came first
Time frame: 240 weeks
serum AFP(alpha fetoprotein), ng/ml
Measured for each subjects at each visits
Time frame: 240 weeks
serum PIVKA-II(Protein Induced by Vitamin K Absence or Antagonist-II), μg/L
Measured for each subjects at each visits
Time frame: 240 weeks
Overall Survival (OS), month
The time from random assignment to death from any cause
Time frame: 240 weeks
tumor size, mm
Utilizing Liver CT or MR examination
Time frame: 240 weeks
Number of participants with treatment-related adverse events
Assessed by CTCAE v4.0
Time frame: 240 weeks
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