thyroid cancer
Conditions
Interventions
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily participated in this study and signed an informed consent form; 2.Completed radical resection of thyroid cancer; 3.Pathologically diagnosed as high-risk differentiated thyroid cancer (DTC): (1)(Intraoperative or gross view of pathological tissue) tumors invaded the tissue outside the thyroid; (2)Incomplete surgical resection; (3)Lung, bone and other distant metastases; (4)Postoperative serum thyroglobulin (TG) suggests distant metastasis; (5)Cervical lymph node metastasis (pathologically positive) + maximum diameter >= 3cm; (6)follicular carcinoma + microscopic vascular invasion> 4; 4.At least two measurable lesions; 5.18-80 years old, ECOG score 0-1 points; 6.The function of major organs meets the following standards within 7 days before treatment: Blood routine examination standard (without blood transfusion within 14 days): (1)Hemoglobin (HB) >= 90g/L; (2)The absolute value of neutrophils (ANC) >= 1.5x10^9/L; (3)Platelet (PLT) >= 80x10^9/L The biochemical inspection shall meet the following standards: (1)Total bilirubin (TBIL) =60ml/min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). 7.Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the study ends; serum or urine pregnancy tests are negative within 7 days before study entry , And must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1.Previous use of Anlotinib Hydrochloride Capsules or similar VEGFR-TKI small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, sorafenib, etc. 2.Received radiotherapy external beam therapy or iodine-131 therapy in the past 3 months; or planned to perform systemic anti-tumor therapy during this study medication period, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and traditional Chinese medicine ( Or have used Mitomycin C within 6 weeks before receiving the trial drug treatment); 3.Pathologically proven to be malignant tumors derived from non-thyroid epithelial cells (including lymphoma, metastatic carcinoma, sarcoma, etc.); 4.Concomitant with other malignant tumors that have not been controlled or are being treated at the same time; 5.Patients have multiple factors that affect oral medications (such as inability to swallow); 6.Accompanied by pleural effusion or ascites, causing respiratory syndrome (>= CTC AE Grade 2 dyspnea [Grade 2 dyspnea refers to shortness of breath during small activities; affecting instrumental activities of daily living]); 7.Patients with any severe and/or uncontrollable disease, including: (1)Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >=100 mmHg) with an antihypertensive drug; (2)Patients with myocardial ischemia or myocardial infarction above grade I and congestive heart failure >=grade 2 (New York Heart Association (NYHA) classification); (3)Sinus bradycardia; or atrioventricular block of more than two degrees, or sinus arrest (except for pacemaker installed); arrhythmia (including QTC >= 480ms); need to use medicine which is known to prolong the QTc interval at the same time, including antiarrhythmic treatments; (4)Active or uncontrolled serious infection (>= CTC AE grade 2 infection); (5)Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; (6)Renal failure requires hemodialysis or peritoneal dialysis; (7)Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8)Poor blood glucose control in diabetic patients (fasting blood glucose (FBG)> 10mmol/L); (9)Urine routines suggest that urine protein is >= ++, and the 24-hour urine protein quantification is confirmed to be greater than 1.0 g. 8.Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping; 9.Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 10.Regardless of the severity, patients with any signs of bleeding or medical history; patients with any bleeding or bleeding event >= CTCAE level 3 within 4 weeks before grouping, and unhealed wounds, ulcers or fractures; 11.Patients have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 12.Have a history of aneurysm; 13.Patients have a history of epilepsy or a neurological disease with ataxia in need of treatment; 14.Patients have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 15.Patients with a history of peripheral nervous system diseases and m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZheng Haitao
Yantai Yuhuangding Hospital
Outcome results
None listed