A Real-world Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.
⁃ Patients voluntarily participate in this study, sign the informed consent form and had good compliance;
⁃ Aged 18 \
• 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\
‣ 1; more than 6 months of expected survival ;
⁃ Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer, radiographically documented disease progression within 18 months of absence of radioactive iodine (RAI) therapy;
⁃ Meet any of the following:
∙ Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH) elevation (≥ 30 mIU/L). The definition of no iodine uptake:
⁃ no iodine uptake initially;
• exist of iodine uptake initially while lost subsequently;
• partially uptake;
• progression disease despite iodine uptake.
‣ The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months.
‣ Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
⁃ At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
⁃ Major organ functions meet the following criteria within 7 days prior to treatment:
∙ Blood routine test criteria (14 days without blood transfusion):
⁃ Hemoglobin (HB) ≥ 85 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• Platelet (PLT) ≥ 80 × 10\^9/L
‣ Biochemical tests need to meet the following criteria:
⁃ Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2 .5×ULN, ALT and AS if liver metastases T ≤ 5 ×ULN;
• Serum creatinine (Cr) ≤ 1 .5 ×ULN or creatinine clearance (CCr) ≥ 60 Ml/min;
⁃ Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 6 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating patients; and males should agree to use contraceptive measures during the study and within 6 months after the end of the study period.