An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer
Overview
- Phase
- Phase 2
- Intervention
- Apatinib
- Conditions
- Refractory Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- objective response rate
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Shengyu Zhou
Deputy director of the physician
Chinese Academy of Medical Sciences
Eligibility Criteria
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):
- •The target lesion was completely deprived of iodine in the treatment of radioactive iodine;
- •The patients were treated with single dose of iodine (3.7 GBq) and the disease progressed in 12 months;
- •The patients were given an iodine treatment interval of less than 12 months, and the dose was greater than that 3.7 GBq \[≥100mCi\], with at least one iodine treatment over 12 months of disease progression;
- •Cumulative doses of radioactive iodine were greater than 22.2 GBq (or more than 600 mCi).
- •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:
Exclusion Criteria
- •The presence of a third interstitial fluid (such as a large amount of pleural effusion and/or peritoneal fluid, pericardial fluid) that cannot be controlled by a drainage or other methods.
- •Before or at the same time with other malignant tumors, except cured skin basal cell carcinoma, cervical carcinoma in situ or other effective treatment of tumors and did not see signs of disease for five years.
- •The patients who used VEGFR-TKI drugs, such as Vandetanib， Cabozantinib， Lenvatinib，Sunitinib，Sorafenib in one month.
- •Inability to swallow, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption.
- •major surgical or severe trauma injuries, fractures, or ulcers before 4 weeks of enrolling , 3 weeks of radiation therapy (except for partial palliative radiation), chemotherapy, and molecular target therapy in three weeks, Treatment with nitrocarbamide or mitomycin before six weeks of enrolling.
- •uncontrolled hypertension (systolic blood pressure of 140mmHg or diastolic pressure is greater than 90mmHg, despite the best drug treatment).
- •Patients used to suffer from severe cardiovascular diseases: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male ≥450ms, female≥470ms); According to NYHA standard, Ⅲ \~ Ⅳ cardiac insufficiency, or heart color indicate left ventricular ejection fraction (LVEF) \< 50%.
- •History of significant hemoptysis within 2 months prior to enrollment or daily hemoptysis is up to 2.5ml;with the trend of haemorrhage or prior treatment with an angiogenesis therapy.
- •Significant clinical significance of bleeding symptoms or a definite bleeding tendency happened in three months prior to screening, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.
- •Active brain metastasis, cancer meningitis, Spinal cord oppressor activity of brain metastases of, cancer, spinal cord compression patients, CT or MRI examination revealed brain or soft meningeal disease (patients who completed treatment and get stable symptoms with brain metastases can be into the group in 21 days prior to screening, without symptoms of cerebral hemorrhage).
Arms & Interventions
apatinib with 500mg qd po
Patients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.
Intervention: Apatinib
Outcomes
Primary Outcomes
objective response rate
Time Frame: 1 year
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).
Secondary Outcomes
- progression-free-survival(PFS)(1 year)
- disease control rate(DCR)(1 year)
- serum Tg、TgAb、calcitonin(1 year)
- Adverse Events(AEs)(1 year)