Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Overview

To evaluate the safety and effectiveness of cell therapy using precision cells Combined With TACE in Advanced Liver Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.

Full Title of Study: “Clinical Study Using Precision Cell Immunotherapy Combination With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

Detailed Description

A total of 40 patients may be enrolled over a period of 1-2 years.

Interventions

  • Procedure: TACE
    • Lipiodol 10-20ml,MMC 8~10mg,EADM20~ 40mg.According to tumor area of maximum diameter,0.1~0.2ml/cm2 Hepatic arterial infusion.
  • Biological: Precision Cells
    • DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PMAT/PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Arms, Groups and Cohorts

  • Experimental: Precision cells combined with TACE
    • Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells:After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment
  • Active Comparator: Transcatheter Arterial Chemoembolization
    • patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: 2 years
  • Progress-free survival
    • Time Frame: 2 years

Secondary Measures

  • Quality of life
    • Time Frame: 2 years
    • Questionnaire will be used.

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18~65 years old, male or female; 2. Life expectancy≥6 months; 3. ECOG score: 0-3; 4. Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out; 5. Enough venous channel, no other contraindications to the separation and collection of white blood cells; 6. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level; 7. Signed informed consent; 8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. Exclusion Criteria:

1. Expected Overall survival < 3 months 2. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus 3. Liver function is Childs Pugh C 4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney 5. Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ningbo Cancer Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Huajun Jin, Study Chair, Shanghai Cell Therapy Research Institute
    • Qijun Qian, Study Chair, Shanghai Cell Therapy Research Institute
    • Jiangtao Wang, Study Director, Ningbo No.5 Hospital (Ningbo Cancer Hospital)
  • Overall Contact(s)
    • Bi Wang, 86-13310088259, biwang0218@126.com

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