Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
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 December 2016
Trial size 100 participants
Trial identifier NCT02026362, SYZ Cell Therapy Co..

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
the foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
(Experimental)
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
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 .
the foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment

Primary Outcomes

Measure
Number of Participants with tumor recurrence or metastasis
time frame: 5years
Time of tumor recurrence or metastasis
time frame: 5 years

Secondary Outcomes

Measure
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
overall survival
time frame: 5 years

Eligibility Criteria

Male or female 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by SYZ Cell Therapy Co...