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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
500 mg Apatinib given orally once a day for 12 wk prior to RAI (131I) treatment.
Nanjing First Hospital
Nanjing, Jingsu, China
RECRUITINGOverall response rate
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria (RECIST v1.1 criteria) in Solid Tumors.
Time frame: 4 month
Incidence of Treatment-Emergent Adverse Events
This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
Time frame: Time interval from start to 3 months after completion of the therapy
Change From Baseline in Serum Thyroglobulin Levels After Treatment With RAI (131I)
Time frame: Baseline, 4 weeks, 12 weeks and 1 month after RAI
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