Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
NCT ID: NCT02026362
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2013-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The foundation treatment after radical operation or RFA
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Beijing 302 Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
HRYZ Biotech Co.
INDUSTRY
Responsible Party
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Locations
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JOE ZHOU
Shenzhen, Guangdong, China
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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SYZ Cell Therapy Co..
Identifier Type: -
Identifier Source: org_study_id