Clinical trial NCT02026362: Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: HCC
DC
CTL
Lead sponsor: HRYZ Biotech Co.
Sponsor class: INDUSTRY
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-sen University
name: Beijing 302 Hospital
name: Fujian Cancer Hospital
First posted: 2014-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with tumor recurrence or metastasis
timeFrame: 5years
measure: Time of tumor recurrence or metastasis
timeFrame: 5 years
Secondary outcomes:
measure: Hepatitis B virus markers figures
timeFrame: an expected average of 18 weeks
measure: Serum hepatitis B virus (HBV)DNA figures
timeFrame: an expected average of 16 weeks
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: JOE ZHOU
state: Guangdong
Study officials:
References: