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)

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

ADCC & TACE

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, ADCC, TACE, immuno therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

ADCC & TACE

TACE

Arm Description

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.

Outcomes

Primary Outcome Measures

Imaging signs

The size of tumor decrease.

Alpha-fetoprotein (AFP)

To decrease AFP to a low level

Glypican-3

To decrease Glypican-3 to a low level

Secondary Outcome Measures

Full Information

NCT ID

NCT03086564

First Posted

March 10, 2017

Last Updated

October 28, 2020

Sponsor

Yuehua Huang

1. Study Identification

Unique Protocol Identification Number

NCT03086564

Brief 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 (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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

October 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yuehua Huang

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

HCC, ADCC, TACE, immuno therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADCC & TACE

Arm Type

Experimental

Arm Description

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.

Arm Title

TACE

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

ADCC & TACE

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

TACE solely in the first day of a clinical course.

Primary Outcome Measure Information:

Title

Imaging signs

Description

The size of tumor decrease.

Time Frame

4 years

Title

Alpha-fetoprotein (AFP)

Description

To decrease AFP to a low level

Time Frame

4 years

Title

Glypican-3

Description

To decrease Glypican-3 to a low level

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lubiao Chen, Dr.

Organizational Affiliation

the third affiliated hospital of sun yet-sen university

Official's Role

Study Chair

Facility Information:

Facility Name

The Third Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial