Relapsed / refractory thyroid cancer
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old; 2. Histologically proven recurrent refractory thyroid cancer, including the following types defined by WHO 2016: 1) thyroid cancer; 2) recurrent malignant tumor; 3) refractory malignant tumor; 3. Positive TSHR expression was determined by immunohistochemistry (IHC) in a laboratory accredited by the sponsor (IRS score> 3) 4. Patients who did not respond to 131 Iodine or Sorafenib or those who gave up Iodine 131 or Sorafenib to themselves; 5. According to RECIST 1.1 standard has at least one measurable lesion; 6. Chemotherapy, radiotherapy, molecular boot therapy and surgery were not received within 4 weeks prior to study initiation, and have been recovered from acute toxic reactions previously treated except for hair loss and peripheral neurotoxicity; 7. Expected survival of = 6 months; 8. The main organs function properly, that is, meet the following criteria: 1) ECOG physical status score is 0-1; 2) The blood test should meet the following criteria: HB=90g/L (no blood transfusion within 14 days); ANC=1.5 × 10^9/L; PLT=80×10^9/L; 3) biochemical tests should meet the following criteria: TBIL=1.5 x ULN (upper limit of normal); ALT and AST=2.5 x ULN; ALT and AST=5xULN if liver metastases; serum Cr=1xULN, endogenous creatinine clearance > 50 ml / min (Cockcroft-Gault formula); 4) Echocardiography =50%, no pericardial effusion confirmed by echocardiography, no clinically significant electrocardiogram findings, no clinically meaningful pleural cavity,> 92% baseline oxygen saturation indoors, 9. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use appropriate methods of contraception either during the experiment and 8 weeks after the last CART (with sterilization or menopause Women who have been at least 2 years old can be considered as having no fertility); 10. Subject voluntarily joined the study, signed informed consent, compliance is good, with follow-up.
Exclusion criteria
Exclusion criteria: 1. In the past 5 years there is other malignant tumor history, but the cured skin basal cell carcinoma and cervical carcinoma in situ except; 2. TSHR-positive tumor cells metastases disease or history in important organs / organs, or TSHR expression in other organs / organs / tissues except thyroid; 3. Allogeneic organ / cell transplantation history; Pregnant or lactating women; 5. Participate in other drug clinical trials within 4 weeks before the study begins; 6. Patients with hypertension who are not well controlled by a single antihypertensive medication (systolic> 140 mmHg, diastolic> 90 mmHg), patients with Grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias Including QT interval = 440ms) or complete cardiac function; Long-term unhealed chest or other parts of the wound or fracture; 8. Those who have a history of substance abuse and who can not be abstinent or who have mental disorders; 9. Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, impaired lung function, etc. 10. There are fungi, bacteria, viruses or other infections that are uncontrollable or require IV antibacterial therapy; 11. For subjects with previously used chemotherapy, =2 hematologic toxicity or =3 non-hematologic toxicity at enrollment according to NCI-CTCAE 4.0 criteria; 12. A known history of HIV or Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) infection; 13. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural / peritoneal / pericardial catheters). Allow use of a dedicated central venous catheter; 14. brain metastasis or symptoms can not control brain metastases; 15. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 16. Myocardial infarction, angioplasty or stenting, unstable angina or other clinically relevant history of heart disease within 12 months prior to entry, New York Heart Association class III or IV cardiomyopathy Failure, atrial or ventricular lymphoid involvement of the subjects; 17. There is a significant immunodeficiency; 18. There was a history of severe hypersensitivity reactions to the main therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab for the prevention and treatment of CRS, and anti-infectives used during the pretreatment Aminoglycosides severe hypersensitivity reaction; 19. There was a history of deep vein thrombosis or pulmonary embolism within the first 6 months before enrollment; 20. Any woman who is fertile or pregnant while undergoing breastfeeding. Women who have undergone sterilization or have been at least 2 years post-menopausal may be considered non-fertile; 21. A history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause damage to the terminal organ or that require systemic immunosuppression / systemic disease modulation over the past two years; 22. Any disease that may interfere with the safety of the study treatment or assessment of efficacy; 23. At the investigator's discretion, subjects have poor compliance, including follow-up visits or compliance with the study participation requirements; 24. Female subjects who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PetCT; | — |
Countries
China
Contacts
Public ContactJian Huang
Second Affiliated Hospital of Zhejiang University
Outcome results
None listed