Metastasis Clinical Trial
Official title:
Evaluating the Safety and Efficacy of Radioactive Iodine (RAI) Treatment of Metastatic and Advanced Differentiated Thyroid Cancers by Pretreatment With Apatinib for the Neoadjuvant Regimen
The purpose of this study is to determine Safety and Efficacy of Radioactive Iodine (RAI) Treatment of Metastatic and Advanced Differentiated Thyroid Cancers by Pretreatment With Apatinib for the Neoadjuvant Regimen
This study is design to prospectively investigate the safety and efficacy of apatinib in
downsizing primary tumors and metastatic lesions in patients with metastatic and advanced
differentiated thyroid cancers before RAI Treatment.
Standard treatment of thyroid cancer includes thyroidectomy, RAI treatment, and levothyroxine
replacement therapy. Before RAI treatment, L-thyroxin replacement therapy should be stopped
to induce TSH elevation, thereby promoting the intake of radioactive iodine in residual or
metastatic lesions. However, the process of withdrawing L-thyroxin for 4-6 weeks might
promote the progression of the tumor. The main hypothesis is that the use of tyrosine kinase
inhibitor will reduce the tumor proliferation or metastasis rate of patients before RAI
Treatment.
Apatinib is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial
growth factor receptor-2. This is a single-institution, single-arm phase 2 clinical trial.
Patients will receive axitinib 500mg qd for up to 12 week. Patients then will receive RAI
Treatment. If the severe adverse effects discontinued study treatment prior to 12 week, the
patient may also receive subsequent RAI treatment at the time of suspension. The follow-up
period was followed up to assess safety and effectiveness.
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