Thyroid cancer
Conditions
Interventions
131 iodine-combined with anlotinib therapy:131 Iodine treatment:
Fixed-dose lung:metastasis 200mCi bone metastasis 250mCi
Anlotinib:
Allotinib 12mg, once a day, taken orally for 2 weeks and discontinu
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study and sign the informed consent form; 2. Distant metastatic differentiated thyroid cancer, after total thyroidectomy or subtotal thyroidectomy, confirmed by histopathology or imaging, with at least one measurable (RECIST1.1) metastatic lesion (CT, MRI, FDG-PET/CT, etc.); 3. Plan to receive RAI treatment, and RAI treatment metastatic iodine ingestion; 4. Age 18~70 years old; 5. ECOG PS score: 0~1 points; Predicted survival of more than 3 months; 6. The function of major organs within 7 days prior to treatment meets the following criteria: Routine blood test criteria (no blood transfusion within 14 days): Hemoglobin (HB) > = 90 g/L Absolute neutrophil value (ANC) > = 1.5×109/L Platelets (PLT) >=80×109/L Biochemical tests should meet the following criteria: Total bilirubin (TBIL) = 60 ml/min; urinalysis to check urine protein =lower limit of normal (50%) 7. Females of childbearing age (such as: women who have not undergone surgical sterilization or less than 1 year after menopause) have a negative blood pregnancy test and must be non-lactating patients; Males and females of childbearing potential agree to use effective contraception and not to donate sperm or eggs from the beginning of signing the informed consent form until 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: Patients with any of the following items will not be enrolled in this study: 1. Patients who have previously used anlotinib hydrochloride or other VEGFR-TKIs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, bevacizumab, etc. Patients who have used RET inhibitors such as LOXO-292, Blu-667. 2. Received other anti-tumor local therapy within the past 3 months, or planned systemic anti-tumor therapy or external beam radiation or other interventional therapy during the drug period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before receiving trial drug treatment). TSH suppression and thyroxine replacement with levothyroxine are not contraindicated. During the study, TCM anti-tumor therapy should not be used at the same time. 3. Have had or currently have other malignancies within 5 years, except for cured carcinoma in situ of the cervix, skin cancer without melanoma, and superficial bladder tumors with the exception of Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-infiltrating basal membrane)] or solid organ, bone marrow transplant patients. 4. Unrelieved toxic reactions greater than CTC AE(5.0) 1 grade due to any prior therapy, excluding alopecia. 5. Those who have a variety of factors that affect oral medication (such as inability to swallow). 6. With pleural effusion or ascites, causing respiratory syndrome (> = CTC AE Grade 2 dyspnea [Grade 2 dyspnea refers to shortness of breath with a small amount of activity; affect instrumental activities of daily living). 7. Patients with any severe and/or uncontrolled disease, including: Patients with hypertension who are still uncontrolled (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg) despite 2 antihypertensive drugs; Significant cardiovascular impairment includes, but is not limited to: >=Class II congestive heart failure (New York Heart Association (NYHA) classification), unstable angina, myocardial infarction, ischemic cardiomyopathy, or stroke within 6 months prior to the first dose Sinus bradycardia above grade 1 (CTCAE 5.0); or more than second-degree atrioventricular block, or sinus arrest (except for those with a pacemaker installed); arrhythmias (including QTC >=480ms); Those who require concomitant use of drugs known to prolong the QTc interval, including anti-arrhythmic therapy; Active or uncontrolled severe infection (>=CTC AE grade 2 infection); Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; Renal failure requiring hemodialysis or peritoneal dialysis; Those with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Poor glycemic control in diabetic patients (fasting blood glucose (FBG) > 10 mmol/L); Those whose urine routine showed urine protein >=++, and confirmed that the 24-hour urine protein was > 1.0 g. 8. Significant surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to grouping. 9. Patients whose imaging shows that the tumor has invaded the perivascular area of important blood vessels, or the investigator judges that the tumor is very likely to invade important blood vessels during the follow-up study and cause fatal hemorrhage. 10. Patients with any signs or history of bleeding constitution, regardless of severity; Patients with any bleeding or bleeding ev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Changes in thyroglobulin levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Degree of bone pain relief;Safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactDai Dong
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed