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

HRYZ Biotech

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Other: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment; Biological: MASCT:Multiple Antigens Specific Cellular Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02026362

SYZ Cell Therapy Co..

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

The foundation treatment after radical operation or RFA

Other group

Description:

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

Treatment:

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

MASCT:Multiple Antigens Specific Cellular Therapy

Experimental group

Description:

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

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