Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

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

Official Title
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Clinical Study Using Precision Cell Immunotherapy Combination With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer

Conditions
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Precision Cell Immunotherapy, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer

Intervention / Treatment
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* Procedure: TACE
* Biological: Precision Cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precision cells combined with TACE<br>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 | Procedure: TACE<br>* Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.<br>Biological: Precision Cells<br>* 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.<br>|
| Active Comparator: Transcatheter Arterial Chemoembolization<br>patients will receive MMC,EADM hepatic arterial infusion,6 cycles. | Procedure: TACE<br>* Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Progress-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaire will be used. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precision Cell Immunotherapy, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer