Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer

Sponsor
Peking Union Medical College Hospital
Study ID
NCT03048877
Phase
PHASE3
Status
Unknown

Conditions

  • Differentiated Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Oral Tablet — DRUG
    Apatinib Mesylate Tablets
  • Placebo Oral Tablet — DRUG
    Placebo Oral Tablet

Study Details

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.

Key Dates

Start date
Dec 31, 2016
Status verified
Apr 2023
Primary completion
Mar 25, 2020
Completion
Dec 31, 2023

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib
    Apatinib Mesylate Tablets
  • Placebo Comparator: Placebo
    Placebo Tablets

Primary Outcome Measure

PFS [ Time Frame: 24 months ]

Related Studies