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SuspendedNCT02026362HCC DC CTLUpdated Oct 18, 2017

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

A Phase 1/2 interventional study of MASCT:Multiple Antigens Specific Cellular Therapy and The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment in Hepatocellular Carcinoma, sponsored by HRYZ Biotech Co.. Suspended at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-18.

Sponsored by HRYZ Biotech Co. · Phase 1/2, Interventional, and Treatment

Why this study was suspended
Interim analysis
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • HCC
  • DC
  • CTL
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 100 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

HRYZ Biotech Co. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    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

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

  • Experimental
    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

    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

  • BiologicalMASCT: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 .

  • OtherThe foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
06

What researchers measure

Primary outcomes

  1. Number of Participants with tumor recurrence or metastasis

    Time frame: 5years

  2. Time of tumor recurrence or metastasis

    Time frame: 5 years

Secondary outcomes

  1. Hepatitis B virus markers figures

    Time frame: an expected average of 18 weeks

  2. Serum hepatitis B virus (HBV)DNA figures

    Time frame: an expected average of 16 weeks

  3. overall survival

    Time frame: 5 years

07

Study locations

1 site
  • JOE ZHOU
    Shenzhen, Guangdong 518006, China
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02026362
Lead 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
Responsible party
Sponsor
First posted
Jan 3, 2014
Start date
Jul 2013
Primary completion
Jul 2017
Completion
Dec 2019 (estimated)
Last update
Oct 18, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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