Clinical trial NCT03086564: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: HCC
ADCC
TACE
immuno therapy
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Imaging signs
timeFrame: 4 years
measure: Alpha-fetoprotein (AFP)
timeFrame: 4 years
measure: Glypican-3
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: the third affiliated hospital of sun yet-sen university
name: Lubiao Chen, Dr.
role: STUDY_CHAIR
References: