UnknownPhase 3

Efficacy of Apatinib in Radioactive Iodine-refractory Differentiated Thyroid Cancer

China118 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged after 18 years (18 is included).
✓. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
✓. Disease progression within 12 months before inclusion.
✓. Subjects must be 131I-refractory / resistant as defined by at least one of the following;
✓. Normal main organ function:
✓. Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
✓. An expected survival of ≥ 3 months.
✓. Pregnancy test (serum) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.

Exclusion criteria

What they're measuring

PFS

Timeframe: 24 months

Trial details

NCT IDNCT03048877

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-25

View on ClinicalTrials.gov More Differentiated Thyroid Cancer trials