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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Apatinib Mesylate Tablets
Placebo Oral Tablet
Nanjing PLA 81 Hospital
Nanjing, Jiangsu, China
Peking Union Medical College Hospital
Beijing, China
PFS
Progression free survival
Time frame: 24 months
DCR
Disease control rate
Time frame: 24 months
ORR
Objective response rate
Time frame: 24 months
DoR
Duration of response
Time frame: 24 months
Changing trend of Tg and TgAb level in serum
Monitor the changes of Tg and TgAb level in serum regularly ( every 2\~8 weeks, and addition examinations were needed if the participants' condition changed ) and draw the relevant changing curve to monitor the change of disease.
Time frame: 24 months
OS
Overall survival
Time frame: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Record the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.