Advanced Liver Cancer, Precision Cells, Transcatheter Arterial Chemoembolization
Conditions
Keywords
Precision Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer
Brief summary
Objectives: 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.
Detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
Interventions
PROCEDURETACE
Lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
BIOLOGICALPrecision 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 cells suspension (1-6×109 Precision cells + 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.
Sponsors
Shanghai International Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
| Progress-free survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 2 years | Questionnaire will be used. |
Countries
China
Contacts
Primary ContactNaiyan Han
Outcome results
None listed