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Hepatocellular CarcinomaPhase 1/2NCT03086564

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)

A Phase 1/2 study testing ADCC & TACE and TACE in people with Hepatocellular Carcinoma, run by Yuehua Huang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
ADCC & TACE and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
1 May 2017to 29 Oct 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

Other trials in China

About this study

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

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.

Read the 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.

Being tested
ADCC & TACE, TACE
Keywords
HCC, ADCC, TACE, immuno therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADCC & TACEBiological

    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.

  • TACEProcedure or surgery

    TACE solely in the first day of a clinical course.

Study groups in NCT03086564
Study groupRoleWhat they receive
ADCC & TACEExperimentalThe 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.
Receives: Biological: ADCC & TACE
TACEActive comparatorEvery 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.
Receives: Procedure: TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging signs

    The size of tumor decrease.

    Measured: 4 years

  2. Alpha-fetoprotein (AFP)

    To decrease AFP to a low level

    Measured: 4 years

  3. Glypican-3

    To decrease Glypican-3 to a low level

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start1 May 2017
  3. Primary completion1 May 2020
  4. Study completion29 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086564
Sponsor's protocol ID
huangyuehuateam
Status last verified
Oct 2020
First submitted
10 Mar 2017
Last updated
30 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ADCC & TACE and TACE in people with Hepatocellular Carcinoma, run by Yuehua Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging signs (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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