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

Hepatocellular Carcinoma Clinical Trial

— HCC DC CTL  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02026362
• Other study ID #: SYZ Cell Therapy Co..
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: December 11, 2013
• Last updated: October 16, 2017
• Start date: July 2013
• Est. completion date: December 2019

Study information

• Verified date: October 2017
• Source: SYZ Cell Therapy Co..
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• 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 .

Other:
• The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment

Locations

Country	Name	City	State
China	JOE ZHOU	Shenzhen	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
SYZ Cell Therapy Co..	Beijing 302 Hospital, Fujian Cancer Hospital, Nanfang Hospital of Southern Medical University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with tumor recurrence or metastasis		5years
Primary	Time of tumor recurrence or metastasis		5 years
Secondary	Hepatitis B virus markers figures		an expected average of 18 weeks
Secondary	Serum hepatitis B virus (HBV)DNA figures		an expected average of 16 weeks
Secondary	overall survival		5 years

External Links

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