Thyroid cancer
Conditions
Interventions
131 iodine combined with lenvatinib treatment group:131 Iodine treatment:
Fixed-dose lung:metastasis 200mCi bone metastasis 250mCi
Lenvatinib:
The SELECT trial reported an average lenvatinib dosage of
therefore, a lenvatinib dose of 16 mg (4 capsules) once daily was adopted. Safety assessments were conducted according to CTCAE v5.0, along with clinical management, including symptomatic treatment an
Lodine-only treatment group:131 Iodine treatment:
Fixed-dose lung:metastasis 200mCi bone metastasis 250mCi
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The patient voluntarily participated in this study and signed the informed consent form. 2. For patients with distant metastatic differentiated thyroid cancer, after total thyroidectomy or subtotal thyroidectomy, and confirmed by histopathology or imaging, if the cumulative dose of 131I treatment exceeds 600mCi, no imaging remission is achieved. 3. At least one measurable (RECIST1.1) metastatic lesion (CT, MRI, FDG-PET/CT, etc.) exists; 4. Plan to receive RAI treatment, and RAI treatment has metastatic lesions for iodine intake; 5. Age: 18 to 70 years old; 6. ECOG PS score: 0-1 point; The expected survival period exceeds three months. 7. The functions of the major organs met the following criteria within 7 days before treatment: (1) Blood routine examination standards (without blood transfusion within 14 days) : Hemoglobin (HB) >=90g/L b) The absolute value of neutrophils (ANC) is >= 1.5×10^9/L c) Platelet count (PLT) >= 80×10^9/L (2) Biochemical tests must meet the following standards: a) Total bilirubin (TBIL) = 1.5 times the upper limit of the normal value (ULN) b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60ml/min; (3) Urine routine test: Urine protein = lower limit of normal value (50%) 7. Women of childbearing age (e.g., those who have not undergone surgical sterilization or have been menopausal for less than one year) must have a negative blood pregnancy test and must be non-lactating patients; Men and women of childbearing age agree to Effective contraceptive measures must be taken from the time of signing the informed consent form until six months after the end of the study, and sperm or egg donation is not allowed.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will not be eligible for this study: 1. Patients who have previously received anti-tumor treatment with lenvatinib or other VEGFR-Tkis, such as anlotinib, Vandetanib, Cabozantinib, sunitinib, sorafenib, bevacizumab, etc. Used RET inhibitors such as Patients with LOXO-292 and Blu-667. 2. Have received other local anti-tumor treatments within the past 3 months, or plan to undergo systemic anti-tumor treatment, external irradiation or other interventional treatments during the medication period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or have used mitomycin C within 6 weeks before receiving the investigational drug treatment). The use of levothyroxine for TSH suppression and thyroid hormone supplementation therapy is not prohibited. During the research period, traditional Chinese medicine for anti-tumor treatment should not be used simultaneously. 3. Patients who have experienced or are currently concurrently suffering from other malignant tumors within the past 5 years, excluding those with cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)] or those who have undergone solid organ or bone marrow transplantation. 4. Unrelieved toxic reactions above CTC AE(5.0) grade 1 caused by any previous treatment, excluding alopecia. 5. Those with multiple factors that affect oral medication (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 light activity; affecting instrumental activities of daily living]). 7. Patients with any severe and/or uncontrolled diseases, including: (1) those with hypertension whose blood pressure remains poorly controlled despite treatment with two antihypertensive drugs (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); (2) Significant cardiovascular damage includes but is not limited to: >= grade II congestive heart failure (New York Heart Association (NYHA) classification), unstable angina pectoris, myocardial infarction, ischemic cardiomyopathy or stroke within 6 months before the first medication; (3) Grade 1 or above sinus bradycardia (CTCAE 5.0); Or more than two degrees of atrioventricular conduction Block, or sinus arrest (except for those with pacemakers installed); Arrhythmia (including QTC>=480ms); It is necessary to use drugs known to prolong the QTc interval simultaneously, including those undergoing anti-arrhythmic treatment; (4) Active or uncontrolled severe 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) Those with a history of immune deficiency, including those who are HIV positive or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; (8) Poor blood glucose control in diabetic patients (fasting blood glucose (FBG) > 10mmol/L); (9) Urine routine test indicates urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0g. 8. Major surgical treatment, incision biopsy or obvious traumatic injury was received within 28 days before grouping. 9. Patients whose imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Changes in thyroglobulin levels;Disease control rate;Safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactDai Dong
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed