NCT03048877

Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer

A Randomized, Double-Blind, Placebo-Controlled Study of Apatinib in Locally Advanced or Metastatic Radioactive Iodine-refractory Differentiated Thyroid Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and lenvatinib which have been approved by food and drug administration (FDA), could not be affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor effectively, which is a proven and effective drug in many solid tumors. A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC ,which enrolled 20 patients and 10 of them had obtained a shout-term efficacy, demonstrating the peculiar potential in treatment of RAIR-DTC. In this study, the investigators aim to further explore the efficacy and safety of apatinib in RAIR-DTC.

Detailed description

Primary Outcome Measure: Progression free survival of apatinib in RAIR-DTC. Secondary Outcome Measures: Disease control rate, objective response rate, duration of response, changes of Tg and TgAb level in serum, overall survival, side effects and quality of life.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Apatinib Oral Tablet	Apatinib Mesylate Tablets
DRUG	Placebo Oral Tablet	Placebo Oral Tablet

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-03-25
• Completion: 2023-12-31
• First posted: 2017-02-09
• Last updated: 2023-04-12

Locations

2 sites across 1 country: China