Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric 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 to treat Advanced Gastric 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 Gastric 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 Chemotherapy in Advanced Gastric Cancer

Conditions
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Precision Cell Immunotherapy, Chemotherapy, Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Biological: Precision Cell Immunotherapy


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 (gastric cancer) were diagnosed by pathological or clinical physicians; 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；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: Expected Overall survival < 6 months; Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month. 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 Chemotherapy treatment:<br>Precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods. | Drug: Chemotherapy<br>* Cisplatin：60mg/m2，5-FU：500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.<br>Biological: Precision Cell Immunotherapy<br>* DC cell suspension (1×10*7 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. PNAT/PMAT cell suspension (1-6×109 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: Chemotherapy<br>Once a week with a total of six times before 60 days prior to the start of drawing blood. | Drug: Chemotherapy<br>* Cisplatin：60mg/m2，5-FU：500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.<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 | 
| 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, Chemotherapy, Advanced Gastric Cancer