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

Phase 1

Suspended

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

• Registration Number: NCT02026362
• Lead Sponsor: HRYZ Biotech Co.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-03
• Primary Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MASCT:Multiple Antigens Specific Cellular Therapy	The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment	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 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

Primary Outcome Measures

Name	Time	Method
Number of Participants with tumor recurrence or metastasis	5years
Time of tumor recurrence or metastasis	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

JOE ZHOU; 🇨🇳 Shenzhen, Guangdong, China