advanced gastric cancer
Conditions
Interventions
Group A:CEA-CAR-T infusion
Group B:HER2-CAR-T infusion
Group C:CEA-HER2-CAR-T infusion
Sponsors
The Third Hospital Affiliated To Army Medical University (Research Institute of surgery)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. histopathological diagnosed with gastric adenocarcinoma; 2. tumor antigen expression in tumor tissue samples is positive (Both CEA and Her2); 3. unresectable locally advanced, Locally recurrent or metastatic advanced gastric cancer,persist or relapse after clinical treatment; 4. allow pre radiotherapy, chemotherapy, targeted therapy,less than 4 weeks; 5. advanced gastric cancer with at lest one measurable lesion; 6. aged 18-75 years old, the Expected lifetime =3 month; 7. ECOG (Eastern Cooperative Oncology Group) 0-1; 8. The standard of blood routine examination should be consistent: WBC 4×10^9/L- 10×10^9/L, ANC=1.0×10^9/L, LC=0.4×10^9/L, HB= 80 g/L, PLT =60×10^9/L; 9. The main organ function is normal, and meet the following standards: (1) Bilirubin 50%normal ECG; (3) blood oxygen saturat=90%if patient has lung metastasis,the clinical team will make decisions; (4) no active seizure disorder; 10. with adequate intravenous access for a single blood collection or intravenous blood collection, and no other blood cell separation contraindications 11. patients must take contraception measures at least 6 months after clinical trails 12. Agrees to the assessment schedule and follow-up plan and to cooperate actively 13. patients must be able to understand and voluntarily signed informed consentimmediate family members can understand and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. T cells of patients cannot expand in pre expansion experiments; 2. Organ failure, such as heart: atrial fibrillation, angina pectoris, cardiac function Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 3. Patients have not yet control severe infection, fever more than 38.5 degree C, or received systemic steroid therapy; 4. Patients with active viruses infection such as hepatitis b, hepatitis c, HIV, syphilis and bacteria or fungi infection; 5. Long term use of immunosuppressive drugs or people with severe autoimmune diseases; 6. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 7. Coagulation abnormalities and severe thrombosis; 8. Severe gastrointestinal obstruction; 9. Patients with allergic reactions to drugs for the treatment of infusion and support; 10. Pregnant or lactating women (women of childbearing age undergo a serum pregnancy diagnosis within 48 hours prior to cell treatment to exclude pregnancy; 11. Any man or woman who has a pregnancy plan within 1 year; 12. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 13. Patients with other factors are not suitable for participation considered by clinical team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate;Tumor imaging;Cytokine IL-6;Cytokine TNF-a;CRP;Copy numbers of CART in vivo; | — |
Countries
China
Contacts
Public ContactBin Wang
Gastroenterology and hepatology department, The Third Hospital Affiliated To Army Medical University (Research Institute of surgery)
Outcome results
None listed