Study on the Treatment of Differentiated Thyroid Carcinoma with Anlotinib

Inclusion Criteria

• •locally advanced or metastatic RAIR-DTC (papillary, follicular \[including Hürthle cell\], and poorly differentiated) progressed within 18 months after the last treatment according to the Response Evaluation Criteria in Solid Tumors, version 1.1
• •Patients with RAIR-DTC should meet at least 1 of the following conditions: (a) the tumor invaded vital organs, cannot be completely removed nor suitable for further iodine treatment, or (b) lesions do not demonstrate iodine uptake on any radioactive iodine scan, or (c) received cumulative RAI activity ≥22.3 GBq (≥600 mCi), or (d) tumors retained iodine uptake but demonstrated radiological examination confirmed disease progression within 18 months after RAI treatment.
• •at least one measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• •life expectancy of at least 6 months
• •adequate main organ function ((a) Hemoglobin (HBG) ≥ 90g/L, (b) neutrophil count (ANC) ≥ 1.5×109/L, (c) platelet count (PLT) ≥ 80×109/L, (d) total bilirubin \< 1.5×ULN (upper limit of normal), (e) alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5×ULN, if accompanied by liver metastases, then ALT and AST ≤ 5 × ULN; (f) serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min; (g) left ventricular ejection fraction ≥ 50% of the normal level
• •Negative pregnancy test (serum or urine) within 7 days prior to enrollment for women of childbearing potential (subjects should use appropriate contraception until 6 months after the last dose)