Thyroid cancer
Conditions
Interventions
Experimental group:Anlotinib with 131I
Control group:131I
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. ECOG PS score: 0~1; Expected survival of more than 3 months; 3. Patients voluntarily participated in this study and signed informed consent; 4. Distant metastatic differentiated thyroid cancer was confirmed by histopathology or imaging, and the patient had at least one measurable (according to RECIST1.1) metastatic lesion (such as lung, bone, brain and other distant metastases) after total or subtotal thyroidectomy. 5. Plan to receive RAI treatment, and whole-body imaging after RAI treatment confirms the presence of at least one iodine-capable metastasis; 6. Major organ functions within 7 days prior to treatment meet the following criteria: (1) Blood routine examination criteria (without blood transfusion within 14 days) : 1) Hemoglobin (HB) >= 90g/L 2) Neutrophil absolute value (ANC) >= 1.5×10^9/L 3) Platelet (PLT) >= 80×10^9/L (2) Biochemical examination shall meet the following standards: 1) Total bilirubin (TBIL) = 60ml/min; (3) Urine protein = (50%) 7. A woman of reproductive age (e.g., a woman who has not undergone surgical sterilization or less than 1 year after menopause) has a negative blood pregnancy test and must be a non-lactating patient; Men and women of childbearing age agree that they must use effective contraception from the beginning of the informed consent and for six months after the end of the study, and must not donate sperm or eggs.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will not be enrolled in this study: 1. Children and adolescents under 18 years of age. 2. Undifferentiated thyroid carcinoma or medullary thyroid carcinoma confirmed by histopathology or imaging. 3. Patients who have previously used any small molecule TKI for anti-tumor therapy, such as antirotinib, Vandetanib, Cabozantinib, Renvastinib, Sunitinib, sorafenib, bevacizumab, etc. Patients who have used RET inhibitors such as LOXO-292, Blu-667. 4. Received other local antitumor therapy within the last 3 months, or planned systemic antitumor therapy or external irradiation or other interventional therapy during the duration of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to receiving the trial drug). TSH inhibition and thyroxine supplementation with levothyroxine are not prohibited. During the study period, Chinese herbal antitumor therapy should not be used simultaneously. 5.Patients who have had or are currently having other malignancies within 5.5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ), and T1 (tumor infiltrating basal membrane)] or solid organ or bone marrow transplantation. 6. Unmitigated toxic effects above CTC AE(5.0) grade 1 due to any previous treatment, excluding hair loss. 7. People who have multiple factors affecting oral medication (such as inability to swallow). 8. Accompanied by pleural effusion or ascites, respiratory syndrome (>=CTC AE grade 2 dyspnea [Grade 2 dyspnea refers to shortness of breath with a small amount of activity; affecting instrumental activities of daily living]). 9. Patients with any severe and/or uncontrolled disease, including: (1) Patients with hypertension who still have unsatisfactory blood pressure control after treatment with 2 antihypertensive drugs (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) classification), 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 of atrioventricular block, or sinus arrest (except when a pacemaker is installed); Arrhythmia (including QTC >=480ms); The need for concurrent use of drugs known to prolong the QTc interval, including antiarrhythmic therapies; (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 requires 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) Poor blood glucose control in diabetic patients (fasting blood glucose (FBG) > 10mmol/L); (9) Urine routine indicated urine protein >=2+, and confirmed 24-hour urine protein quantity > 1.0 g. 10. Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days prior to grouping. 11. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the investigators to be highly likely to invade important blood ve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Tg;AE;HRQoL; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS; | — |
Countries
China
Contacts
Public ContactWei Zheng
Tianjin Medical University General Hospital
Outcome results
None listed