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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.
A total of 40 patients may be enrolled over a period of 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Cell Immunotherapy | Experimental | 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. |
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| Chemotherapy | Active Comparator | Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years | |
| Progress-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naiyan Han | Contact | +86 21 6023 6666 | naiyan.han@simcgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Naiyan Han | Shanghai International Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai International Medical Center | Recruiting | Shanghai | Shanghai Municipality | 201318 | China |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Precision Cells | Biological | 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. |
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