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This is a single-center, open-label, single arm,exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.
This is a single-center, open-label, single arm,exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.
The primary endpoint is objective response rate(ORR),the secondary endpoints include progression-free-survival(PFS);disease control rate(DCR);serum Tg、TgAb、calcitonin;safety.
If any case happens as following,including withdrawing informed consent form(ICF)、unbearable toxicity or adverse reactions、other conditions which investigators think the patients are unsuitable to go on trail,the patient will not go on trial any longer,or every subject will obtain study treatment until tumor progress with CT/MRI proof.The indicators of efficacy and safety will be always observed during the trail process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib with 500mg qd po | Experimental | Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib is an oral tyrosine kinase inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | ORR is defined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to Response Evaluation Criteria Solid Tumors(RECIST 1.1). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free-survival(PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. | 1 year |
| disease control rate(DCR) |
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Inclusion Criteria:
≥18 years old,gender limitation.
The pathologic subtype of thyroid carcinoma, which was confirmed by histopathological histology, included iodine refractory thyroid papillary carcinoma and follicular carcinoma, medullary thyroid carcinoma and undifferentiated carcinoma.
Patients with at least one measurable lesion (RECIST1.1), at least one measurable lesion after the treatment (spiral CT scan length to diameter 10 mm or higher, according with the requirement of RESCIST version 1.1 standard).
Radioactive iodine deficiency (according with one of the following conditions):
Patients who underwent at least one failure of standard chemotherapy can be recommended to get into the group.
Organs function have to be compliant with the following specifications:
ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L; TBIL≤1.5×ULN; ALT &AST ≤2.5×ULN ; ALT &AST ≤5×ULN in patients with hepatic metastasis; BUN & Cr≤1×ULN, CCR≥50mL/min (Cockcroft-Gault formula); Normal coagulation function (INR<1.5 or PT\
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengyu Zhou, professor | Contact | 13520852899 | typhoonwho@126.com | |
| Hongzhe Wang, doctor | Contact | 18911052235 | aiesecarrow@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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single group,apatinib 500mg po qd,d1-28
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no parallel,no control
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Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1).
| 1 year |
| serum Tg、TgAb、calcitonin | Evaluating the change of serum level of Tg,TgAb or calcitonin,assessed up to 12 months. | 1 year |
| Adverse Events(AEs) | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 1 year |
| D013959 | Thyroid Diseases |