Gastric Cancer, Liver Metastasis
Conditions
Keywords
gastric cancer, liver metastasis, PIK-HER2 cells, dendritic cell-precision multiple antigen T cells
Brief summary
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
A total of 40 patients may be enrolled over a period of 1-2 years.
Interventions
BIOLOGICALPIK-HER2
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.
BIOLOGICALDC-PMAT
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.
Sponsors
Second Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 65 years old, male or female 2. Life expectancy \> 6 months 3. Eastern Cooperative Oncology Group (ECOG) score: 0-2 4. The stomach or gastroesophageal junction carcinoma with hepatic metastasis 5. Adenocarcinoma 6. The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels 7. 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 8. Blood routine conforms to the requirements of the blood sampling 9. Signed informed consent 10. Patients with fertility are willing to use contraceptive method.
Exclusion criteria
1. Expected Overall survival \< 6 months 2. Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc. 3. Serum creatinine \> 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) \> 5 times of the normal;total bilirubin \> 100μmol/L 4. Without signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival | 2 years | — |
| Quality of life | 2 years | Quality of life core questionnaire will be used. |
Countries
China
Contacts
Primary ContactQijun Qian, PHD
Backup ContactHuajun Jin, PHD
Outcome results
None listed