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

NCT02026362 | Suspended Phase 1

• 1 other identifier: SYZ Cell Therapy Co..
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; DC; CTL

Outcome Measures

Primary Outcomes (2)

• Number of Participants with tumor recurrence or metastasis

  5years

• Time of tumor recurrence or metastasis

  5 years

Secondary Outcomes (3)

• 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

Study Arms (2)

The foundation treatment after radical operation or RFA

OTHER

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

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

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

Interventions

MASCT:Multiple Antigens Specific Cellular Therapy BIOLOGICAL

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

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

MASCT:Multiple Antigens Specific Cellular Therapy; The foundation treatment after radical operation or RFA

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;
• 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.

Sponsors & Collaborators

• HRYZ Biotech Co.: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-sen University: collaborator
• Beijing 302 Hospital: collaborator
• Fujian Cancer Hospital: collaborator

Study Sites (1)

JOE ZHOU

Shenzhen, Guangdong, 518006, China

Location

Related Links

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: January 3, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2019
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

CN (1)