NCT04180007

Study of Neoadjuvant Regimen for Radioactive Iodine Treatment of Metastatic and Advanced Differentiated Thyroid Cancers

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Thyroid
• Metastasis
• Apatinib

Interventions

Type	Name	Description
DRUG	Apatinib	500 mg Apatinib given orally once a day for 12 wk prior to RAI (131I) treatment.

Timeline

• Start date: 2019-04-10
• Primary completion: 2020-04-10
• Completion: 2020-05-30
• First posted: 2019-11-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: China