Malignant Bone Tumor and STS
Conditions
Interventions
TILs Re-infusing:TILs ACT
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. in the past with pathology diagnosed cancer lesions as malignant bone and soft tissue tumor recurrence/metastasis patients. 2. must have had a line or two line of bone and soft tissue sarcomas systemic treatment; 3. only with lung metastases, but is not sensitive to radiotherapy or chemotherapy or biological agents (other parts except by imaging of accurate evaluation). 4. the participants must have a suitable for resection of living tissue area or malignant effusion can isolate TILs. 5. patients aged between 8-70, the power of attorney signed by legal guardians of minors and close to the file; 6. subjects were willing and able to accept to provide informed consent; 7. to accept treatment in patients with ECOG score of 0 or 1, and within 7 days beginning by peripheral lymphocyte clearance; 8. any treatment for malignant tumor, including radiotherapy, chemotherapy and biological agents, must be stopped before 28 days of TILs; 9. with fertility potential participants must be willing to begin when informed consent approved effective birth control method, and the lymphatic clearance plan within 1 year after the completion of the last implementation. The approved birth control methods are as follows: hormonal contraceptives (namely the pill, injection, implants, transdermal patches, vaginal ring); The intrauterine device (IUD); Tubal ligation or a hysterectomy. Vasal ligation of subjects/partner status; Implanted or injected contraceptives; Add spermicide and condoms. 10. Those can stick to study access plan and other agreement requirements.
Exclusion criteria
Exclusion criteria: 1. need intravenous antibiotics, blood coagulation dysfunction or cardiovascular, respiratory or other major medical diseases of the immune system of active systemic infection; 2. activity in patients with viral hepatitis; 3. Within 7 days before 3, into the group, the absolute neutrophil count (ANC) 2.5 times of the normal; 7. Within 7 days before 7, into the group, creatinine clearance 1.5 times of the normal; 9. Within 7 days before 9, into the group, the childbearing age women serum pregnancy test positive; 10. confirmed that HIV infection; 11. myocardial ischemia ecg clues; 12. more than 40 subjects heart ultrasound left ventricular ejection fraction < 45%; pulmonary function test (lungs) prove that forced expiratory value (FEV) 1 < 65% forecast or forced vital capacity (FVC) < predictive value of 65%; 13. patients with history of adoptive cell therapy; 14. known to have severely weakened immune system, or need to long-term use of glucocorticoid and immunosuppressive patients; 15. severe heart, liver, kidney disease patients; 16. patients with inherited or acquired blood coagulation disorders; 17. suffering from severe nerve, spirit and endocrine diseases; 18. the previous Common treatment-related Adverse Events Toxicity standards (Common Toxicity Criteria for Adverse Events, CTCAE v 4.03) is greater than 2, into the group of peripheral neuropathy, except miss or vitiligo. 19. primary immunodeficiency; 20. organ or history of hematopoietic stem cell transplantation; 21. chronic steroids (prednisone dragon < except 10 mg/D); 22. patients, pregnant or breastfeeding; 23. there are serious mental illness can interfere with fully informed consent; 24. past history of diseases of the immune system, including in the activity, ever known or suspected possible autoimmune disease. Checkpoint inhibitors side effects, vitiligo, psoriasis, type 1 diabetes, has ease of childhood asthma, has alleviate atopic side effects. Hypothyroidism on hormone replacement of subjects will not be excluded. 25. significant symptoms of COPD, asthma, or other chronic lung disease in patients with a history of; 26. the history of the second malignant tumor (in the past five years was diagnosed); 27. the activity of the known history of the central nervous system transfer of meningitis or cancer; Lesions was stable, no new or expanding the transfer of evidence, and at the start of peripheral lymphocyte clearance did not use steroids, at least 7 days before such subjects can still participate in; 28. 30 days before the cells back to lose vaccination vaccine; 29. patients with other studies, for the treatment of TILs or drug allergy: used for non clear pith lymphopenia syndrome (NMA - LD) (cyclophosphamide, sodium and fluorine dara marina); IL - 2; Aminoglycoside antibiotics (streptomycin, gentamicin); TIL injection products agents, including human serum albumin (HSA), IL - 2 and dextran 40. 30. the judgment of any other conditions can significantly increase the risk of participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FPS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;disease control rate,DCR;duration of response, DOR;overall survival, OS; | — |
Countries
China
Contacts
Public ContactHua Yingqi
Shanghai General Hospital
Outcome results
None listed