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Hepatocellular CarcinomaPhase 1/2HCC DC CTLNCT02026362

Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).

A Phase 1/2 study testing MASCT:Multiple Antigens Specific Cellular Therapy and The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment in people with Hepatocellular Carcinoma, run by HRYZ Biotech Co. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group' in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in China. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
MASCT:Multiple Antigens Specific Cellular Therapy and The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Jul 2013to Dec 2019
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is diagnosed as hepatocellular carcinoma(HCC);
  • The patient underwent radical operation of HCC within 8 weeks before enrollment;
  • The number of tumors≤2；
  • No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava;
  • No portal lymph node metastasis；
  • No extra-hepatic metastasis;
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  • Complete tumor resection without residual tumor at the surgical margins should be confirmed by enhanced CT or MRI imaging within 4 week (including 4 weeks) after radical operation;
  • If an increased serum AFP level was detected of the patient before the radical operation, the AFP level should be returned to normal in 8 weeks;
  • Child-Pugh Score ≤9;
  • ECOG Performance status (ECOG-PS) ≤2 ;
  • The expected survival time > 2 years;
  • Tests of blood,liver and kidney should meet the following criteria：
  • WBC>3×109/L
  • Neutrophil counts >1.5×109/L
  • Hemoglobin ≥85 g/L
  • Platelet counts≥50×109/L
  • PT is normal or The extend time <3s
  • BUN≤1.5 times the upper-limit ,
  • Serum creatinine≤ 1.5 times of the upper-limit
  • Sign the informed consent.

Who cannot join

  • Women who is pregnant or during breast feeding or plan to pregnant in 2 years;
  • Extra-hepatic metastasis or liver residual tumor;
  • Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava;
  • 6 months before enrollment: the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) was longer than 3 months;
  • 6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
  • Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment;
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  • Positive for HIV antibody or HCV antibody;
  • Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
  • Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma);
  • . Patients with organ failure;
  • Patients with serious mental disease;
  • Drug addiction in 1year before enrollment (including alcoholics);
  • Participated in other clinical trials in 3 months before screening;
  • Other reasons the researchers think not suitable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • JOE ZHOU

    Shenzhen, Guangdong, 518006

Other trials in China

About this study

Official title: Randomized, Open-label, Multi-center Clinical Trial to Compare the Efficacy and Safety of MASCT Group' and 'Non-treatment Group' in Patient Undergone Curative Resection( RFA or Operation) for Hepatocellular Carcinoma .MASCT That Expresses Multiple Antigens Specific Cellular Therapy,Autologous Immune Cytotoxic of T-lymphocytes(CTL) Induced by Dendritic Cell(DC) Loaded With Multiple Antigens

To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group' in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in China.

Being tested
MASCT:Multiple Antigens Specific Cellular Therapy, The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Keywords
HCC, DC, CTL
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • MASCT:Multiple Antigens Specific Cellular TherapyBiological

    autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens .

  • The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatmentOther

Study groups in NCT02026362
Study groupRoleWhat they receive
The foundation treatment after radical operation or RFAOtherThe foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Receives: Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
MASCT:Multiple Antigens Specific Cellular TherapyExperimentalautologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens
Receives: Biological: MASCT:Multiple Antigens Specific Cellular Therapy; Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment

What is being measured

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

  1. Number of Participants with tumor recurrence or metastasis

    Measured: 5years

  2. Time of tumor recurrence or metastasis

    Measured: 5 years

Secondary outcomes (3)

  1. Hepatitis B virus markers figures

    Measured: an expected average of 18 weeks

  2. Serum hepatitis B virus (HBV)DNA figures

    Measured: an expected average of 16 weeks

  3. overall survival

    Measured: 5 years

Timeline

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

  1. First posted3 Jan 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2017
  4. Study completionDec 2019 (estimated)

Why it stopped: Interim analysis

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026362
Sponsor's protocol ID
SYZ Cell Therapy Co..
Acronym
HCC DC CTL
Status last verified
Oct 2017
First submitted
11 Dec 2013
Last updated
18 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MASCT:Multiple Antigens Specific Cellular Therapy and The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment in people with Hepatocellular Carcinoma, run by HRYZ Biotech Co. 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 20 inclusion and 14 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: paused, as of the sponsor's last update on 18 Oct 2017. 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?

Results are not available in the source record.

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?

Number of Participants with tumor recurrence or metastasis (time frame: 5years). The study lists 2 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 NCT02026362.

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 18 Oct 2017.

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