Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by SYZ Cell Therapy Co..
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Information provided by (Responsible Party):
SYZ Cell Therapy Co..
ClinicalTrials.gov Identifier:
NCT02026362
First received: December 11, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SYZ Cell Therapy Co..:

Primary Outcome Measures:
  • Number of Participants with tumor recurrence metastasis as a Measure of effectiveness [ Time Frame: 2years ] [ Designated as safety issue: No ]
  • The time duration of Participants from operation to tumour recurrence or metastasis as a Measure of effectiveness [ Time Frame: 2years ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 2years ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


Secondary Outcome Measures:
  • Hepatitis B virus markers figures [ Time Frame: an expected average of 18 weeks ] [ Designated as safety issue: No ]
  • Serum hepatitis B virus (HBV)DNA figures [ Time Frame: an expected average of 16 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • T cell subsets figures [ Time Frame: an expected average of 16weeks ] [ Designated as safety issue: No ]
  • cytokine secretion figures [ Time Frame: an expected average of 16weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 .
Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026362

Locations
China, Guangdong
JOE ZHOU Recruiting
Shenzhen, Guangdong, China, 518006
Contact: PING CHEN, Master    00860755-86964231    chenping@thyx.com   
Principal Investigator: GUO YA BING, PHD         
Principal Investigator: XIA JIAN CHUAN, PHD         
Principal Investigator: ZHANG QI, PHD         
Sponsors and Collaborators
SYZ Cell Therapy Co..
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
  More Information

Additional Information:
No publications provided

Responsible Party: SYZ Cell Therapy Co..
ClinicalTrials.gov Identifier: NCT02026362     History of Changes
Other Study ID Numbers: SYZ Cell Therapy Co..
Study First Received: December 11, 2013
Last Updated: September 30, 2014
Health Authority: China: Ministry of Health

Keywords provided by SYZ Cell Therapy Co..:
HCC
DC
CTL

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014