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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Jingzhou Central Hospital | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric cancer.
40 patients with stage Ⅰ~Ⅲ Gastric Cancer,who had received surgery and kept their tumor tissue,will be randomly divided into group A(receive Ag-D-CIK treatment and chemotherapy) or group B(just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Sham Comparator | After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up. |
|
| Ag-D-CIK | Experimental | After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| Quality of life (QOL) | 3 years | |
| Phenotypic analysis of T cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hai Y Liu, Professor | Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center | Guangzhou | Guangdong | 510000 | China | ||
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|
| Ag-D-CIK | Biological | 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32. |
|
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
| 1 years |
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) | 1 years |
| Jingzhou Central Hospital Immunotherapy center |
| Jingzhou |
| Hubei |
| 434020 |
| China |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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