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Completed

NCT Number: 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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

ADCC & TACE

Biological

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

Procedure

TACE solely in the first day of a clinical course.

Primary outcomes

  1. Imaging signs

    Time frame: 4 years

    The size of tumor decrease.

  2. Alpha-fetoprotein (AFP)

    Time frame: 4 years

    To decrease AFP to a low level

  3. Glypican-3

    Time frame: 4 years

    To decrease Glypican-3 to a low level

Sponsors and collaborators

Lead sponsor

Yuehua Huang

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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