Thyroid cancer
Conditions
Interventions
Radioactive iodine-125 seed group:Radioactive iodine-125 seed
Joint group:Radioactive iodine-125 seed and Anlotinib
Sponsors
Hebei Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed informed consent. 2. Locally advanced or metastatic differentiated thyroid carcinoma was confirmed by histopathology. 3. Have at least one measurable lesion (RECIST 1.1). 4. Aged 18-85 years; ECOG PS score: 0-2; Survival is expected to exceed 6 months. 5. Major organ functions within 7 days prior to treatment shall meet the following criteria: (1) Standard of routine blood examination (without transfusion within 14 days) : hemoglobin (HB) >= 100g/L, neutrophil absolute value (ANC) >=1.5x10^9/L, platelet (PLT) >= 80x10^9/L; (2) Biochemical examination shall meet the following standards: Total bilirubin (TBIL) = 60ml/min; (3) Cardiac ultrasound: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%). 6. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study ends; Have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Men should consent to patients who must use contraception during the study period and for six months after the study period ends.
Exclusion criteria
Exclusion criteria: 1. Received approved or under development systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, and Chinese medicine therapy (Chinese medicine therapy with clear anti-tumor indications can also be enrolled after 4-week washout period); TSH inhibition with levothyroxine and thyroxine supplementation are not prohibited. 2. Patients have had or are currently having other malignancies within 5 years, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, and ductal carcinoma in situ of the breast (DCIS). 3. Unmitigated toxic reactions higher than grade 1 of CTC AE(5.0) due to any previous treatment, excluding hair loss. 4. Patients who have multiple factors affecting oral medication (such as inability to swallow). 5. Accompanied by pleural effusion or ascites, causing respiratory syndrome (>=CTC AE grade 2 dyspnea). 6. Patients with any severe and/or uncontrolled medical condition, including: (1) The use of 1-2 antihypertensive drugs still not ideal blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); (2) Significant cardiovascular impairment includes, but is not limited to: >= grade II congestive heart failure (New York Heart Association (NYHA) rating), unstable angina, myocardial infarction, ischemic cardiomyopathy, or stroke within 6 months before first medication; (3) Sinus bradycardia of grade 1 and above (CTCAE 5.0); Or more than a second degree atrioventricular block, or sinus arrest (except for those with pacemakers installed); Arrhythmia (including QTC >=480ms); Concomitant use of drugs known to prolong the QTc interval, including antiarrhythmic therapies, is required; (4) Active or uncontrolled severe infection (>=CTC AE grade 2 infection); (5) Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; (6) Renal failure requiring hemodialysis or peritoneal dialysis; (7) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8) Patients with diabetes had poor blood glucose control (fasting blood glucose (FBG) > 10mmol/L). 7. Major surgical treatment, open biopsy, or significant traumatic injury was received within 28 days prior to treatment. 8. A history of aneurysm with the possibility of rupture. 9. Those who have a history of epilepsy or have ataxic neurological diseases requiring treatment. 10. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders. 11. Patients with a history of peripheral nervous system disease and muscle strength below grade 3. 12. Patients who have participated in or are in clinical trials of other antitumor drugs within four weeks. 13. In the investigator's judgment, there is a concomitant disease that seriously endangers the patient's safety or interferes with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival;Thyroglobulin; | — |
Countries
China
Contacts
Public ContactGao Zhen
Hebei Provincial People's Hospital
Outcome results
None listed