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Trial record 157 of 315 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT03086564
First received: March 10, 2017
Last updated: August 2, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Hepatocellular Carcinoma Biological: ADCC & TACE Procedure: TACE Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Imaging signs [ Time Frame: 4 years ]
    The size of tumor decrease.

  • Alpha-fetoprotein (AFP) [ Time Frame: 4 years ]
    To decrease AFP to a low level

  • Glypican-3 [ Time Frame: 4 years ]
    To decrease Glypican-3 to a low level


Estimated Enrollment: 70
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: May 1, 2020
Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADCC & 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.

Biological: ADCC & TACE
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.
Active Comparator: TACE

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.

Procedure: TACE
TACE solely in the first day of a clinical course.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03086564

Contacts
Contact: Yanlin Huang, Bachelor +8615626459901 hyanlin3@mail2.sysu.edu.cn
Contact: Yuehua Huang, MD.&PHD +8613318818899 huangyh53@mail.sysu.edu.cn

Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Yurong Gu, Doctor    8620-85252702    guyr163@163.com   
Contact: Yuehua Huang, Doctor    86-18922103516    huangyh53@sysu.edu.cn   
Sponsors and Collaborators
Yuehua Huang
Investigators
Study Chair: Lubiao Chen, Dr. the third affiliated hospital of sun yet-sen university
  More Information

Responsible Party: Yuehua Huang, Director, Provincial Key Laboratory of Liver, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03086564     History of Changes
Other Study ID Numbers: huangyuehuateam
Study First Received: March 10, 2017
Last Updated: August 2, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University:
HCC
ADCC
TACE
immuno therapy

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Chlorotrianisene
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2017