Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA). (HCC DC CTL)
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Shenzhen, Guangdong, China, 518006
- JOE ZHOU
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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|
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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
|
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
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with tumor recurrence or metastasis
Time Frame: 5years
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5years
|
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Time of tumor recurrence or metastasis
Time Frame: 5 years
|
5 years
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Secondary Outcome Measures
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
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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
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SYZ Cell Therapy Co..
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