Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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A total of 40 patients may be enrolled over a period of 1-2 years.

Official Title
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A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis

Conditions
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Liver Metastasis, Gastric Cancer

Intervention / Treatment
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* Biological: PIK-HER2
* Biological: DC-PMAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 65 years old, male or female Life expectancy > 6 months Eastern Cooperative Oncology Group (ECOG) score: 0-2 The stomach or gastroesophageal junction carcinoma with hepatic metastasis Adenocarcinoma The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL Blood routine conforms to the requirements of the blood sampling Signed informed consent Patients with fertility are willing to use contraceptive method. Exclusion Criteria: Expected Overall survival < 6 months Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L Without signed informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIK-HER2 cells<br>PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. | Biological: PIK-HER2<br>* 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.<br>|
| Active Comparator: DC-PMAT<br>DC-PMAT treatment will be performed every 3 weeks with a total of three periods. | Biological: DC-PMAT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival |  | 2 years | 
| Quality of life | Quality of life core questionnaire will be used. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, liver metastasis, PIK-HER2 cells, dendritic cell-precision multiple antigen T cells