Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA). (HCC DC CTL)
Primary Purpose
Hepatocellular Carcinoma
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MASCT:Multiple Antigens Specific Cellular Therapy
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, DC, CTL
Eligibility Criteria
Inclusion Criteria:
- The patient is diagnosed as hepatocellular carcinoma(HCC);
- The patient underwent radical operation of HCC within 8 weeks before enrollment;
- The number of tumors≤2;
- No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava;
- No portal lymph node metastasis;
- No extra-hepatic metastasis;
- 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;
- 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;
- Child-Pugh Score ≤9;
- ECOG Performance status (ECOG-PS) ≤2 ;
- The expected survival time > 2 years;
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
- Sign the informed consent.
Exclusion Criteria:
- Women who is pregnant or during breast feeding or plan to pregnant in 2 years;
- Extra-hepatic metastasis or liver residual tumor;
- Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava;
- 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;
- 6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
- Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment;
- Positive for HIV antibody or HCV antibody;
- Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
- Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma);
- . Patients with organ failure;
- Patients with serious mental disease;
- Drug addiction in 1year before enrollment (including alcoholics);
- Participated in other clinical trials in 3 months before screening;
- Other reasons the researchers think not suitable.
Sites / Locations
- JOE ZHOU
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
The foundation treatment after radical operation or RFA
MASCT:Multiple Antigens Specific Cellular Therapy
Arm Description
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
Outcomes
Primary Outcome Measures
Number of Participants with tumor recurrence or metastasis
Time of tumor recurrence or metastasis
Secondary Outcome Measures
Hepatitis B virus markers figures
Serum hepatitis B virus (HBV)DNA figures
overall survival
Full Information
NCT ID
NCT02026362
First Posted
December 11, 2013
Last Updated
October 16, 2017
Sponsor
HRYZ Biotech Co.
Collaborators
Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Beijing 302 Hospital, Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02026362
Brief Title
Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Suspended
Why Stopped
Interim analysis
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HRYZ Biotech Co.
Collaborators
Nanfang Hospital, Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Beijing 302 Hospital, Fujian Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, DC, CTL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The foundation treatment after radical operation or RFA
Arm Type
Other
Arm Description
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Arm Title
MASCT:Multiple Antigens Specific Cellular Therapy
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
MASCT:Multiple Antigens Specific Cellular Therapy
Intervention 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 .
Intervention Type
Other
Intervention Name(s)
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
Primary Outcome Measure Information:
Title
Number of Participants with tumor recurrence or metastasis
Time Frame
5years
Title
Time of tumor recurrence or metastasis
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Hepatitis B virus markers figures
Time Frame
an expected average of 18 weeks
Title
Serum hepatitis B virus (HBV)DNA figures
Time Frame
an expected average of 16 weeks
Title
overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is diagnosed as hepatocellular carcinoma(HCC);
The patient underwent radical operation of HCC within 8 weeks before enrollment;
The number of tumors≤2;
No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava;
No portal lymph node metastasis;
No extra-hepatic metastasis;
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;
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;
Child-Pugh Score ≤9;
ECOG Performance status (ECOG-PS) ≤2 ;
The expected survival time > 2 years;
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
Sign the informed consent.
Exclusion Criteria:
Women who is pregnant or during breast feeding or plan to pregnant in 2 years;
Extra-hepatic metastasis or liver residual tumor;
Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava;
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;
6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment;
Positive for HIV antibody or HCV antibody;
Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma);
. Patients with organ failure;
Patients with serious mental disease;
Drug addiction in 1year before enrollment (including alcoholics);
Participated in other clinical trials in 3 months before screening;
Other reasons the researchers think not suitable.
Facility Information:
Facility Name
JOE ZHOU
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518006
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.nfyy.com/
Description
Related Info
URL
http://www.sysucc.org.cn/
Description
Related Info
URL
http://www.zssy.com.cn/
Description
Related Info
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Multiple Antigen Specific Cell Therapy (MASCT) for Hepatocellular Carcinoma(HCC) Patients After Radical Resection or Radio Frequency Ablation(RFA).
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