A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined With Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment (BTRHBVAPHCLCDCCTCHBVHCCT)
Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, ADCC, TACE, immuno therapy
Eligibility Criteria
Inclusion Criteria:
- Patients with history of hepatitis B infection
- Stage B or C in Barcelona Clinic Liver Cancer(BCLC)
- Eastern Cooperative Oncology Group(ECOG) scores <= 2.(without portal vein involved)
- Patients have been unable to be performed surgery or liver transplant
- Patients are appropriate to be performed TACE
- 18 or over 18 years old
- Patients haven't received radiation therapy or chemotherapy or immunotherapy
- Normal renal function
- Blood routine test:Hb>=9g/L,white cell count>=1.5*10^9/L,platelet count>=50*10^9
- Liver function: bilirubin<=50ummol/L,aspartate aminotransferase (AST) or alanine aminotransferase (ALT)<=5 times the upper limit of normal
- Child-Pugh score<=9
- Human Chorionic Gonadotropin (HCG) test negative(-) if patients are women of reproductive ages
- Women of reproductive ages promise to contracept until therapy course has been finished for 3 months
- Patients who have signed up informed consents
Exclusion Criteria:
- Extrahepatic metastasis of hepatocellular carcinoma
- History of embolism, chemotherapy or radiation
- History of major surgery in last 4 weeks
- History of radiofrequency ablation in last 6 weeks
- Acute infections in last 2 weeks
- Child-Pugh scores>9
- Patients with hepatic encephalopathy
- Patients with ascites needed drainage
- HCC with portal vein involved
- Patients have history of cancer
- Patients have history of HIV
- Pregnant women
- Patients with severe diseases like cardiac dysfunction
- Patients with mental illness that influence signing informed consents
- HBV infection combined with other types of hepatitis
- Patients with autoimmune diseases
- Immunosuppressant drugs users
- Patients cannot follow our trial principle
Sites / Locations
- The Third Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ADCC & TACE
TACE
The first course : Patients in the first day of a clinical course will be performed TACE solely and keep 40ml blood sample as baseline sample for scientific research;in the 17th day, 10ml blood will be taken to culture activated dendritic cells;in 29th day, cyclophosphamide(CY) 250mg/m2 is used through an intravenous drip;in 31th day,patients are going to be performed TACE,1-2*10^8 activated dendritic cells are dripped through peripheral vein, 40ml blood sample will be taken for clinical research, simultaneously. The 31th day in the first course is the same as the first day of the second course, then we come to next therapy course. 31 days are a course of treatment, health conditions of patients who participate in will be monitored closely in the process. After previous 3-courses followed-up period, one course will be changed into 93 days.
Every course: In the first day,patients are performed TACE solely and taken 40ml blood as baseline sample for scientific research;in the 29th day,patients are needed to reach hospital to check related indicators. In the 31th day, patients are performed TACE again. The 31th day is the same as the first day in the second course. 31 days are a course of treatment, health conditions of patients who participate in will be monitored closely in the process. After previous 3-courses followed-up period, one course will be changed into 93 days.