Advanced thyroid cancer
Conditions
Interventions
Experimental group:Apatinib mesylate combined with camrelizumab
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and voluntarily sign the informed consent form; 2. Aged 18-75 years; 3. ECOG score 0-2 points; 4. Estimated survival time >= 12 weeks; 5. Patients with advanced thyroid cancer who are inoperable or cured by local treatments such as microwave ablation, and have the following three types of thyroid cancer diagnosed by histopathology or cytology (satisfying one of them is sufficient): (1) Locally advanced or metastatic differentiated thyroid cancer, including papillary thyroid carcinoma (including follicular subtypes and poorly differentiated subtypes, etc.) and thyroid follicular carcinoma (including Hürthle cell subtypes, etc.); (2) Locally advanced or metastatic medullary thyroid carcinoma; (3) Anaplastic thyroid carcinoma; 6. If the patient with differentiated thyroid cancer, it needs to meet the definition of radioiodine refractory (meet one of the following conditions): (1) At least one measurable lesion has completely lost its iodine uptake function during radioactive iodine therapy; (2) Although the lesion has the ability to take iodine, there is at least one measurable lesion, and disease progression is still occurring within 12 months after 131I treatment; (3) The cumulative radiation iodine treatment dose >= 22.2 GBq (>= 600 mCi), the last radioiodine treatment was within 6 months before enrollment; 7. If the patient with differentiated thyroid cancer, starting from the screening period, the TSH level should be at the inhibitory level (=10mm or the short diameter of enlarged lymph node is >=15 mm; the lesions that have received local treatment in the past, according to RECIST vl.1 Standards, which can be used as target lesions after the progress is clear); 9. The function of main organs is normal, that is, it meets the following standards: (1) The standard of routine blood examination should meet: HB>=90g/L (no blood transfusion within 28 days); ANC>=1.5x10^9/L; PLT>=100x10^9/L; (2) Biochemical examination should meet the following standards: serum total bilirubin =60ml/min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%); (4) International normalized ratio (INR)= 2+, 24-hour urine protein quantification can be performed, 24-hour urine protein quantification <1.0g can be included in the group); 10. Females of childbearing age should agree to use effective contraception during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating patients, and willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to therapeutic drugs; 2. Urine routines suggest that urine protein is >=++, and the 24-hour urine protein quantitative is confirmed to be greater than 1.0g; 3. Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) have been used within 28 days before the first use of the drug in this study. Except for the use of thyroid stimulating hormone (TSH) suppression therapy; 4. Hypertension that cannot be controlled stably by drugs is specified as: systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg; previous hypertensive crisis or hypertensive encephalopathy; 5. Past or present severe bleeding (bleeding >30ml within 3 months), hemoptysis (>5ml fresh blood within 4 weeks) or thromboembolic events (including transient ischemic attack) within 12 months; 6. Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure New York Heart Association (NYHA) class >= 2; ventricular arrhythmia requiring medical therapy; left ventricular ejection fraction (LVEF) 450ms (male); QTc>470ms (female) (QTc interval is calculated by Fridericia formula; if QTc is abnormal, it can be tested three times continuously at 2 minutes interval, and the average value is used); 8. Surgery (except for biopsy) or surgical incision did not heal completely within 28 days before being selected for this study; 9. Brain metastases that have not undergone surgery and/or radiation therapy, or brain metastases that have been previously treated, but there is no clinical imaging evidence that the disease is stable; 10. Patients whose imaging studies have shown that the tumor has invaded the carotid aorta or the investigator has determined that the tumor is likely to invade important blood vessels during the follow-up study and cause fatal bleeding; 11. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 12. Patients with a history of immunodeficiency or active autoimmune diseases, including but not limited to HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 13. Use immunosuppressive agents or systemic hormone therapy within 14 days before starting the research treatment to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones); 14. Known significant liver disease history, including but not limited to known hepatitis B virus (HBV) infection and HBV DNA positive (>=1x10^4/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>=1x10^3/ml), or liver cirrhosis, etc.; 15. Patients who have previously received immune checkpoint inhibitor therapy (including but not limited to PD-1 inhibitors, PD-L1 and CTLA-4 inhibitors); 16. According to the judgment of the investigator, patients who are deemed unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Duration of remission (DOR);Objective response rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactDu Wei
He'nan Cancer Hospital
Outcome results
None listed