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| Name | Class |
|---|---|
| Cure&Sure Biotech Co., LTD | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gp96 group | Experimental | autologous gp96 vaccination + basal treatment for gastric cancer |
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| control group | Other | Oxaliplatin+S-1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous gp96 vaccination | Biological | Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery. gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 2 years | |
| Number of participants with adverse events related to gp96 immunotherapy | A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason. And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 3.0 criteria. | participants will be followed from the day of the first vaccination to the 30th day after the last vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in antigen specific T cells | Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. | within 3 days before the first vaccination and within 3 days after the 10th vaccination |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Peng, MD | Contact | 086-10-66938028 | zihpeng@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Chen, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Oxaliplatin+S-1 | Drug | Treatment will be start at the 5th week after the surgery. S-1: 40~60mg bid,d1~14 q3W; oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W 6 cycles. |
|
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| 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |