Trial | NCT02873442  Report issue

Title

Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Clinical Study Using Precision Cell Immunotherapy Combination With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
A total of 40 patients may be enrolled over a period of 1-2 years.
Study Started
Aug 31
2016
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Aug 31
2018
Anticipated
Last Update
Oct 07
2016
Estimate

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.

Precision cells combined with TACE Experimental

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

Transcatheter Arterial Chemoembolization Active Comparator

patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Criteria 

Inclusion Criteria:

Age 18~65 years old, male or female;
Life expectancy≥6 months;
ECOG score: 0-3;
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;
Enough venous channel, no other contraindications to the separation and collection of white blood cells;
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；
Signed informed consent；
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:

Expected Overall survival < 3 months
The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
Liver function is Childs Pugh C
Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
No Results Posted