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Objectives:
The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.
Methods:
This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
A total of 40 patients may be enrolled over a period of 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIK-HER2 cells | Experimental | PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. |
|
| DC-PMAT | Active Comparator | DC-PMAT treatment will be performed every 3 weeks with a total of three periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIK-HER2 | Biological | DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | 2 years | |
| Quality of life | Quality of life core questionnaire will be used. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qijun Qian, PHD | Contact | +86-21-65580677 | qianqj@sino-gene.cn | |
| Huajun Jin, PHD | Contact | +86-21-81875372 | hj-jin@Hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qijun Qian, PHD | Eastern Hepatobiliary Surgery Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Recruiting | Shanghai | 200438 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19269014 | Background | Marx AH, Tharun L, Muth J, Dancau AM, Simon R, Yekebas E, Kaifi JT, Mirlacher M, Brummendorf TH, Bokemeyer C, Izbicki JR, Sauter G. HER-2 amplification is highly homogenous in gastric cancer. Hum Pathol. 2009 Jun;40(6):769-77. doi: 10.1016/j.humpath.2008.11.014. Epub 2009 Mar 9. | |
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|
| DC-PMAT | Biological | DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 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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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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