Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Objectives: To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy 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
-----------------
A total of 40 patients may be enrolled over a period of 1-2 years.

Official Title
-----------------
Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Conditions
-----------------
Precision Cell Immunotherapy, Chemotherapy, Advanced Malignancies

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Biological: Precision Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
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; 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 Cell Immunotherapy<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 Cells<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. 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: Chemotherapy<br>Chemotherapy: 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?
-----------------
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 |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Precision Cell Immunotherapy, Chemotherapy, Advanced Malignancies