Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma (NCT03167385) | Clinical Trial Compass
UnknownPhase 2
Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma
China20 participantsStarted 2017-03-22
Plain-language summary
This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with locally advanced or metastatic differentiated thyroid carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Informed consent.
✓. Histopathology confirmed locally advanced or metastatic differentiated thyroid carcinoma, with measurable lesions (RECIST 1.1).
✓. Age:18-75 years, ECOG（Eastern Cooperative Oncology Group） Score:0-2, Expected survival period ≥ 3 months.
✓. Patients with disease progression which was confirmed by imaging in 18 months, and meet any one of the following four:
✓. The tumor invades important organs, and cannot be resectted completely, the remnant thyroid tissue is extensive and not suitable for further iodine treatment.
✓. Lesions have no iodine affinity.
✓. The cumulative dose of RAI (radioactive iodine) ≥ 600mCi or 22GBq.
✓. Patients with disease progression confirmed by radiological examination within 18 months of last RAI.
Exclusion criteria
✕. Patients with past apatinib treatment or have received two or more small molecular TKI (Tyrosine Kinase Inhibitor) drugs.
✕. Patients accepted external beam radiation therapy or iodine - 131 therapy in recent three months, or patients plan to receive the other systemic anti-tumor treatment during the study.
✕. Patient with history of another malignant disease within past 5 years, cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor are spared.
What they're measuring
1
disease control rate
Timeframe: within two weeks of drug administration
Trial details
NCT IDNCT03167385
SponsorTianjin Medical University Cancer Institute and Hospital