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 February 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: February 16, 2014
Last verified: February 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:

  • The patient is diagnosed as hepatocellular carcinoma(HCC) by pathological/ radiological test
  • No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (PEIT, RFA or operation) in 8 weeks.at least 4 weeks later ,The tumor's removal should be perfectly confirmed by radiological test; on dynamic CT, dynamic MRI or on angiography
  • Child-Pugh Score should be less than 9
  • ECOG Performance status (ECOG-PS) is less than 2 or equal to
  • Patient's remaining life-time should be expected at least more than 2 years
  • Patient should meet below conditions by blood test, kidney and liver function test Re-evaluation is possible during screening:
  • Leukocyte count is more than 3 * 109/L)
  • Absolute Neutrophil Count (ANC) is more than or equal to 1,000/µL
  • Hemoglobin is more than or equal to 85 g/L
  • Thrombocyte count is more than (5 *1010/L)
  • Prothrombin Time(PT) normal or Overtime is not more than 3 seconds
  • Blood urea nitrogen(BUN) and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit
  • patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self,the guardian or the legal representative signed on written consent

Exclusion Criteria:

  • Hepatocellular carcinoma has been transferred or liver residual tumor by pathological/ radiological test
  • The carcinoma has been invaded to main portal vein or major branch hepatic vein
  • Patient who has disease history of immune deficiency (which can be worse by immunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease,multiple sclerosis and adolescent-occurred insulin dependent diabetes)
  • Patient who has disease history of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate cancer or carcinoma in situ of the uterine cervix
  • Patient who has serious disease in other organs after tumor resection.
  • Patient has serious mental disease by sub- investigator's opinion
  • Patient who is incongruent to this clinical trial by sub- investigator's opinion
  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: PEGGY CHEN, Master    00860755-86964231    chenping@thyx.com   
Principal Investigator: GUO YA JUN, PHD         
Principal Investigator: XIA JIAN CHUAN, PHD         
Sub-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: February 16, 2014
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 14, 2014