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

October 16, 2017 updated by: SYZ Cell Therapy Co..

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518006
        • JOE ZHOU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient is diagnosed as hepatocellular carcinoma(HCC);
  2. The patient underwent radical operation of HCC within 8 weeks before enrollment;
  3. The number of tumors≤2；
  4. No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava;
  5. No portal lymph node metastasis；
  6. No extra-hepatic metastasis;
  7. 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;
  8. 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;
  9. Child-Pugh Score ≤9;
  10. ECOG Performance status (ECOG-PS) ≤2 ;
  11. The expected survival time > 2 years;

  12. 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
  13. Sign the informed consent.

Exclusion Criteria:

  1. Women who is pregnant or during breast feeding or plan to pregnant in 2 years;
  2. Extra-hepatic metastasis or liver residual tumor;
  3. Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava;
  4. 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;
  5. 6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
  6. Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment;
  7. Positive for HIV antibody or HCV antibody;
  8. Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
  9. Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma);
  10. . Patients with organ failure;
  11. Patients with serious mental disease;
  12. Drug addiction in 1year before enrollment (including alcoholics);
  13. Participated in other clinical trials in 3 months before screening;
  14. Other reasons the researchers think not suitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: The foundation treatment after radical operation or RFA
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
EXPERIMENTAL: MASCT:Multiple Antigens Specific Cellular Therapy
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
Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Biological: MASCT:Multiple Antigens Specific Cellular Therapy
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with tumor recurrence or metastasis
Time Frame: 5years
5years
Time of tumor recurrence or metastasis
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years
Hepatitis B virus markers figures
Time Frame: an expected average of 18 weeks
an expected average of 18 weeks
Serum hepatitis B virus (HBV)DNA figures
Time Frame: an expected average of 16 weeks
an expected average of 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SYZ Cell Therapy Co..

Collaborators

Sun Yat-sen University
Fujian Cancer Hospital
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

January 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYZ Cell Therapy Co..

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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