Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
This trial has been suspended.
|Treatments||masct:multiple antigens specific cellular therapy, the foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment|
|Phase||phase 1/phase 2|
|Sponsor||SYZ Cell Therapy Co..|
|Collaborator||Nanfang Hospital of Southern Medical University|
|Start date||July 2013|
|End date||June 2017|
|Trial size||100 participants|
|Trial identifier||NCT02026362, SYZ Cell Therapy Co..|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Number of Participants with tumor recurrence or metastasis
time frame: 5years
Time of tumor recurrence or metastasis
time frame: 5 years
Hepatitis B virus markers figures
time frame: an expected average of 18 weeks
Serum hepatitis B virus (HBV)DNA figures
time frame: an expected average of 16 weeks
time frame: 5 years
All participants from 20 years up to 70 years old.
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.
|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|
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