locally advanced or metastatic radioactive iodine (RAI) refractory differentiated thyroid carcinoma
Conditions
Interventions
1:oral
Sponsors
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. aged more than 18 years old, male or female; 2. locally advanced or metastatic differentiated thyroid carcinomas (papillary, follicular, Hurthle, poorly differentiated),There is at least one measurable lesion to be treated; 3. disease progression occurred within 12 months prior to inclusion; 4. radioactive iodine refractory (satisfying one of the following conditions):(1) the target lesion completely loses the iodine uptake function during radioiodine therapy; (2) single radioactive iodine therapy for patients within 12 months of receiving (more than 3.7 GBq [= 100mCi]) and target lesion disease progression;(3) patients every two radioiodine treatment time interval is less than 12 months, more than 3.7 GBq / dose is more than 100mCi], at least in 12 months after the treatment of disease more than one iodine;(4) received a total dose of radioactive iodine therapy for more than 22.2 GBq (600 mCi); 5. the main organ function is normal, meet the following requirements: routine blood test should be consistent (14 days without blood transfusion): HB = 90g/L); ANC = 1.5 * 109/L; PLT = 80*10^9/L; Biochemical tests should meet the following criteria: BIL <1.5 times normal value limit (ULN); ALT and AST<2.5 * ULN; if there is liver metastasis, then ALT and AST<5 x ULN; C less than 1 * ULN) serum Cr, creatinine clearance rate was higher than 50ml/min (Cockcroft-Gault formula); 6. ECOG PS 0-2 points; 7. the expected survival time more than 3 months; 8. women of childbearing age must have pregnancy tests (serum or urine) within 7 days before admission to the group. The result is negative and voluntary. During the observation period and 8 weeks of the last given apatinib after using appropriate contraceptive methods; for men, should be hand Surgical sterilization, or consent during the observation period, and the last piece of apatinib given appropriate methods within 8 weeks after using contraception; 9. patients voluntarily entered the study and signed informed consent (ICF); 10. the patients with good compliance can follow up the curative effect and adverse reactions according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. differentiated histologic subtypes of other thyroid carcinomas (e.g., medullary carcinoma, lymphoma, or sarcoma); 2. One months after VEGFR-TKI small molecule drugs, such as vandetanib (vandetanib), Kaba with imatinib (Cabozantinib), lenvatinib, sunitinib, Sola Fini and other patients; 3. had hypertension, antihypertensive drugs can not be reduced to the normal range (systolic / diastolic blood pressure of >90 >140 mmHg mmHg), suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation of male >450 MS, female >470 MS) and heart failure; 4. there are many factors that influence the absorption of oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 5. is the risk of gastrointestinal bleeding of patients can not into the group, including the following: (1) with active peptic ulcer lesions, and fecal occult blood (+ +); (2) within 3 months of melena and hematemesis history; 6. abnormal coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN), with bleeding tendency; 7. screening within 2 months before there was blood or cough, hemoptysis daily amounted to half a teaspoon (2.5ml) or above; 8. 12 months before the screening, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 9. prior to screening, radiotherapy for antithyroid thyroid cancer was carried out in January; 10. within the first month of the screening, there were active bleeding, ulcers, intestinal perforation, intestinal obstruction, and those who had undergone the operation (if the operation was performed 28 days later, the wound should be completely restored); 11. there is uncontrollable infection when screening; 12. pregnant or lactating women; 13. clearly suffering from depression (HAMD score more than 17 points, see Annex 5) 14. other physicians considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactGao Zairong
Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed