gastrointestinal tumors
Conditions
Interventions
Regional delivery:Regional delivery chimeric antigen receptor gene-modified autologous T cells immunotherapy
Systemic infusion:Systemic infusion chimeric antigen receptor gene-modified autologous T cells immunotherapy
Sponsors
Peking University Shougang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) with pathology and the imaging clearly diagnosed with stage 3 or 4 malignant gastrointestinal tumor, persist or relapse after clinical treatment; (2) tumor antigen expression in tumor tissue samples is positive; (3) at least one month after the last conventional treatment; (4) patients respiratory function is normal, chest imaging tip basic normal, if patient has lung metastasis,the clinical team will make decisions ; (5) patients aged 18 to 80 years old male and female; (6) patients physical condition score of 0 to 2 points according to the ECOG (WHO). (7) patients must take contraception measures at least 6 months after clinical trails; (8) patients must be able to understand and voluntarily signed informed consent; (9) patients and immediate family members can understand and signed informed consent, and may not replace signature midway through the study.
Exclusion criteria
Exclusion criteria: (1) T cells of patients cannot expand in pre expansion experiments; (2) Patients undergoing hormone therapy; (3) Patients have not yet control severe infection, fever more than 38.5 degree C, or blood and related fluid tip show infection such as bacteria, viruses; (4) Patients with low immunity obviously or hypoalbuminemia; (5) Patients with active viruses infection such as hepatitis b, hepatitis c, HIV , yphilis and bacteria or fungi infection; (6) Patients with brain metastases more than 3, or single matastase larger than 1 cm in diameter, brain metastases in patients with clinical symptoms, and have progression within a month; (7) Patients with history of active autoimmune disease; (8) Patients with allergic reactions to drugs for the treatment of infusion and support; (9) Patients with acute coronary syndrome and cerebrovascular disease; (10) Patients cardiac function is abnormal ; (11) Patients with obvious active inflammatory disease of the pleura, pericardium; (12) Patients with abnormal liver function; (13) Patients with abnormal renal function, with nephrotic syndrome and other related kidney disease; (14) Patients with abnormal blood and clotting function; (15) Patients with history of mental or cognitive impairment, may limit their understanding of informed consent, execution, and treatment compliance; (16) Patients and families poor compliance; (17) Patients with other factors are not suitable for participation considered by clinical team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor imaging;Cytokine IL-6;Cytokine TNF-a;CRP;Copy numbers of CART in vivo; | — |
Countries
China
Contacts
Public ContactJin Gu
Outcome results
None listed