Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)
Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in
 patients with Differentiated Thyroid Cancer.
Inclusion Criteria:

 1. Signed and dated informed consent

 2. Histological documentation of Differentiated Thyroid Cancer ,With measurable disease
 (using RECIST1.1)

 3. ECOG PS:0-1,Life expectancy of more than 6 months

 4. Subjects must be 131I-refractory / resistant as defined by at least one of the
 following:

 -  Lesions that do not demonstrate iodine uptake on any radioiodine scan

 -  Cumulative activity of 131I of >600 mCi or 22 gigabequerels (GBq)

 -  Lesion that demonstrate iodine uptake on any radioiodine scan,but has progressed
 by RECIST 1.1 within 18 months of 131I therapy

 5. main organs function is normal

 Exclusion Criteria:

 1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as
 Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)

 2. Subjects received radiotherapy external exposure or 131I within 3 months prior to the
 first dose of study drug or plan to be received any anti-cancer treatment during study

 3. Patients suffering from other malignancies currently or within 5 years, except for
 cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder
 cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma
 invasion into lamina propria) ]

 4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous
 treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by
 oxaliplatin

 5. Patients with factors that could affect oral medication (such as dysphagia etc.)

 6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2
 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount
 of activities, affecting Instrumental activities of daily life])

 7. Patients underwent major surgical treatment，open biopsy or significant traumatic
 injury within 28 days prior to assignment