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

Last updated: October 16, 2017
Sponsor: SYZ Cell Therapy Co..
Overall Status: Suspended

Phase

1/2

Condition

Liver Cancer

Cancer/tumors

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02026362
SYZ Cell Therapy Co..
  • Ages 20-70
  • All Genders

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.

Eligibility Criteria

Inclusion

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 firstbranch, 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 beconfirmed by enhanced CT or MRI imaging within 4 week (including 4 weeks) afterradical operation;

  8. If an increased serum AFP level was detected of the patient before the radicaloperation, 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

  1. Sign the informed consent.

Exclusion

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 firstbranch, hepatic vein, inferior vena cava;

  4. 6 months before enrollment: the period of systemic and continuous use ofimmunomodulatory 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 theimmunosuppressive 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 monthsbefore enrollment;

  7. Positive for HIV antibody or HCV antibody;

  8. Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoidarthritis, Buerger's disease, multiple sclerosis and diabetes type 1);

  9. Patient who suffered from other malignant tumor in 5 years before enrollment (exceptskin 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

Total Participants: 100
Study Start date:
July 01, 2013
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • JOE ZHOU

    Shenzhen, Guangdong 518006
    China

    Site Not Available

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