Neoplasms

Gland and Hormone Related Diseases

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Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Apatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.

Apatinib is an oral tyrosine kinase inhibitor.

Shengyu Zhou, professor

Hongzhe Wang, doctor

Dawei Wu, professor

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.

A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

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).

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.

Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）.

Evaluating the change of serum level of Tg，TgAb or calcitonin,assessed up to 12 months.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer	NCT03199677	Refractory Canc...	Apatinib	18 Years - 75 Years	ChineseAMS
A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer	NCT03199677	Refractory Canc...	Apatinib	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for apatinib,refractory thyroid cancer