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Hepatocellular CarcinomaPhase 2NCT04317248

"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma

A Phase 2 study testing Cyclophosphamide and Multiple Signals loaded Dendritic Cells Vaccine in people with Hepatocellular Carcinoma, run by Yuehua Huang at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Cyclophosphamide and Multiple Signals loaded Dendritic Cells Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
4 sitesChina
Study dates
1 Apr 2020to 30 Apr 2022
Phase
Phase 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In accordance with AASLD guidelines for the diagnosis of hepatocellular carcinoma，histology or imaging confirmed as primary hepatocellular carcinoma
  • Patients with history of hepatitis B infection
  • Male and female adult subjects (18～70 years old)
  • Patients haven't received radiation therapy or chemotherapy or immunotherapy
  • Normal renal function
  • Blood routine test: Hb>=9g/dL, white cell count>=1.5*10^9/L, platelet count>=50*10^9/L
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  • Liver function: bilirubin<=50umol/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 oHistory 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
Show all 16Show fewer
  • Patients with ascites needed drainage
  • Patients have history of other 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

4 sites in 1 country.

Yuehua HYuang, doctorate contact

0086-13822232795

huangyh53@mail.sysu.edu.cn

Yifan Lian, doctorate contact

0086-13824441190

lianyf@mail3.sysu.edu.cn

China4 sites, 4 recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong, 510000

    Li Liu, doctorate, 0086-18602062738, fimmu@gmail.com

    Recruiting

  • Sun Yat-sen University Cancer center

    Guangzhou, Guangdong, 510000

    Ming Shi, doctorate, 0086-13925006889, shiming@sysu.edu.cn

    Recruiting

  • Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Jiajun Zhang, doctorate, 0086-13751725506, zhjiajun@mail.sysu.edu.cn

    Recruiting

  • The Third Affiliated Hospital of Zhongshan University

    Guangzhou, Guangdong, 510630

    Yanhua Bi, 0086-13829710921, 821771928@qq.com

    Recruiting

Other trials in China

About this study

Official title: Precision Study on "Cocktail" Therapy to Improve the Efficacy of Hepatitis B-related Hepatocellular Carcinoma

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, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.

Read the detailed description

Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, control group will receive radical surgery or TACE or targeted agent treatment solely; another group (experimental group) after enrollment will radical surgery or TACE or targeted agent treatment in the first course. Then 20ml blood is taken for multiple signals loaded dendritic cells (MSDCV) culture (cell culture takes 7 days). Low dose (250mg/m^2) CY treatment will be performed on patients two days before the MSDCV treatment. The MSDCV combined CY therapy will perform per 4 weeks, total 6 times. All patients are evaluated the safety and efficacy of treatment by monitoring their blood parameters, tumor indicators and imaging examinations at each visit.

Being tested
Cyclophosphamide, Multiple Signals loaded Dendritic Cells Vaccine
Keywords
hepatocellular carcinoma, hepatitis B, Dendritic cells vaccine, cell therapy
Medical subject headings
Carcinoma, Hepatocellular, Hepatitis B

What participants receive

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

  • CyclophosphamideDrug

    Also called Endoxan

    Intravenous drip，250mg/m^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）

  • Multiple Signals loaded Dendritic Cells VaccineBiological

    Also called MSDCV

    one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, intravenous driptotal 6 times;

Study groups in NCT04317248
Study groupRoleWhat they receive
MSDCV immune therapy combined with radical surgery therapyExperimentalMultiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time before the first time of MSDCV immune therapy
Receives: Drug: Cyclophosphamide; Biological: Multiple Signals loaded Dendritic Cells Vaccine
Radical surgery therapyNo interventionHepatocellular Carcinoma Radical surgery therapy: one time at a good operation time
MSDCV immune therapy combined with TACE therapyExperimentalMultiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: the first time of TACE therapy must perform before the first time of MSDCV immune therapy， then perform when necessary according to subjects condition
Receives: Drug: Cyclophosphamide; Biological: Multiple Signals loaded Dendritic Cells Vaccine
TACE therapyNo interventionTranscatheter Hepatic Arterial Chemoembolization (TACE) therapy: perform when necessary according to Subjects condition
MSDCV immune therapy combined with targeted agents therapyExperimentalMultiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, total 6 times; Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition
Receives: Drug: Cyclophosphamide; Biological: Multiple Signals loaded Dendritic Cells Vaccine
Targeted agents therapyNo interventionTargeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition

What is being measured

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

  1. Progression-Free-Survival (PFS), month

    The time from randomization until first documented progression or death from any cause，whichever came first

    Measured: 240 weeks

Secondary outcomes (5)

  1. serum AFP(alpha fetoprotein）, ng/ml

    Measured for each subjects at each visits

    Measured: 240 weeks

  2. serum PIVKA-II(Protein Induced by Vitamin K Absence or Antagonist-II), μg/L

    Measured for each subjects at each visits

    Measured: 240 weeks

  3. Overall Survival (OS), month

    The time from random assignment to death from any cause

    Measured: 240 weeks

  4. tumor size, mm

    Utilizing Liver CT or MR examination

    Measured: 240 weeks

  5. Number of participants with treatment-related adverse events

    Assessed by CTCAE v4.0

    Measured: 240 weeks

Timeline

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

  1. First posted23 Mar 2020
  2. Study start1 Apr 2020
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317248
Sponsor's protocol ID
2019B110233002
Status last verified
Oct 2020
First submitted
7 Oct 2019
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide and Multiple Signals loaded Dendritic Cells Vaccine in people with Hepatocellular Carcinoma, run by Yuehua Huang at 4 sites 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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 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 4 sites 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 phase mean?

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?

Results are not available in the source record.

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

Contact Yuehua HYuang, doctorate (0086-13822232795, huangyh53@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free-Survival (PFS), month (time frame: 240 weeks). 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 NCT04317248.

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 29 Oct 2020.

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