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)

NCT03086564 | Completed Phase 1 DMC

• 1 other identifier: huangyuehuateam
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; ADCC; TACE; immuno therapy

Outcome Measures

Primary Outcomes (3)

• Imaging signs

  The size of tumor decrease.

  4 years

• Alpha-fetoprotein (AFP)

  To decrease AFP to a low level

  4 years

• Glypican-3

  To decrease Glypican-3 to a low level

  4 years

Study Arms (2)

ADCC & TACE

EXPERIMENTAL

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

TACE

ACTIVE COMPARATOR

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

Interventions

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.

ADCC & TACE

TACE PROCEDURE

TACE solely in the first day of a clinical course.

TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuehua Huang: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Antibody-Dependent Cell Cytotoxicity

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytotoxicity, Immunologic; Immune System Phenomena

Study Officials

• Lubiao Chen, Dr.

  the third affiliated hospital of sun yet-sen university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Provincial Key Laboratory of Liver

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 22, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: October 29, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

CN (1)