digestive system tumor
Conditions
Interventions
A:CART cells transfusion by tumor intervention
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: With CEA expression positive advanced gastric cancer, rectal cancer / with expression of GPC3 positive advanced hepatocellular carcinoma / with mesothelin expression positive advanced pancreatic cancer of male or female patients, after several rounds of chemotherapy, radiotherapy, target to therapy, frequent recurrence, no effective drug for the treatment, and the function of the whole body in good condition, such kind of patients can participate in this clinical trials. Specific criteria: 1. tumor histological examination confirmed as CEA/GPC3/ mesothelin positive expression; 2. Aged between 18 and 69 years; 3. persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients; 4. tumor is too big to surgical resection; 5. life expectancy greater than 6 months; 6. satisfactory organ and bone marrow function as defined by the following: (1) creatinine 55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit; 7. without bleeding disorder or coagulation disorders; 8. Dont allergy to Radiocontrast agent; 9. birth control; 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis; 11. Voluntary informed consent is given.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 3. patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before; 4. Four weeks before recruit accepted radiation therapy; 5. Previously treatment with any gene therapy products; 6. Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 7. Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases); 8. Patient with severe acute hypersensitive reaction; 9. Taking part in other clinical trials; 10. Study leader considers not suitable for this tiral.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokines IL-1beta;cytokine IL-2R;cytokine IL-6;cytokine IL-8;cytokine IL-10;cytokine TNF-alpha;copy numbers of CART in vivo;Tumor marker v;tumor size; | — |
Countries
China
Contacts
Public ContactWentao Li
Fudan University Shanghai Cancer Center
Outcome results
None listed