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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.
At present, multiple anti-angiogenesis drugs for thyroid cancer of clinical research are ongoing worldwide, and most of which achieved fairly good therapeutic effect. To date, sorafenib has been approved for the treatment of radioactive iodine refractory DTC. Apatinib is a highly selective VEGFR2 inhibitor that reduces the angiogenesis of tumor efficiently, and had been proven to be effective in many solid tumors. In this study, the investigators aim to further explore the efficacy and safety of apatinib in locally advanced or metastatic differentiated thyroid carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experitmental | Experimental | Continuous oral intake of Apatinib Mesylate (500mg), once a day, until progression of disease or severe adverse effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | oral intake of Apatinib Mesylate 500mg once a day until progression of diesase or severe adverse effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate | percentage of patients who have achieved complete response, partial response and stable disease to overall therapeutic intervention patients | within two weeks of drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | time that passes from the day the participants received the apatinib and the date on which disease progresses or the date on which the patient dies, from any cause. | 2 years |
| overall survival |
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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:
Patients general condition meeting the following:
Haemoglobin (HBG) ≥ 90 g/L, neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 80×109/L, total bilirubin (TBIL)< 1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5×ULN (ALT and AST < 5×ULN if have liver metastasis), SCr (serum creatinine) <1.5×ULN, left ventricular ejection fraction ≥ 50% of normal.
Past history of less than one kind of tyrosine kinase inhibitor.
Pregnancy test (serum or urine) has to be performed in woman of childbearing age within 7 days before enrolment and the test result must be negative. Patients enrolled should take appropriate contraceptive measures during the study until the 6th month post the last administration of study drug. For male participants, (previous surgical sterilization accepted), agreement to take appropriate methods of contraception during the study until the 6th month post the last administration of study drug is required.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Gao, MD | Contact | 862223340123 | 3150 | gaoming@tjmuch.com |
| Xiangqian Zheng, MD | Contact | 862223340123 | 3150 | xiangqian_zheng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Gao, MD | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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percentage of patients who are alive after a certain time period after they were treated
| 2 years |
| objective response rate | percentage of patients who have achieved complete response and partial response to overall therapeutic intervention patients | 2 weeks |