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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The foundation treatment after radical operation or RFA<br>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<br> <br> |
| Experimental: MASCT:Multiple Antigens Specific Cellular Therapy<br>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<br>* 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 .<br>Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with tumor recurrence or metastasis |  | 5years | 
| Time of tumor recurrence or metastasis |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B virus markers figures |  | an expected average of 18 weeks | 
| Serum hepatitis B virus (HBV)DNA figures |  | an expected average of 16 weeks | 
| overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, DC, CTL