Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Study Overview
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Brief Summary
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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
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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 Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer

Conditions
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Precision Cells, 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<br>Precision Cells combined with Transcatheter Arterial Chemoembolization: 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 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.<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 Cells, Transcatheter Arterial Chemoembolization, Advanced Liver Cancer