Thyroid cancer
Conditions
Interventions
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years (including 18 and 75 years old); 2. ECoG: Patients with 0-2 points; 3. Patients with expected survival >= 3 months; 4. Patients with thyroid cancer that cannot be removed by operation, ineffective iodine treatment and insensitive to radiotherapy shall have at least one measurable focus, the length and diameter of CT scan of tumor focus shall be >= 10 mm, and meet the requirements of Reist 1.1. 5. Patients with refractory radioiodine (meeting one of the following conditions): (1) The target lesion completely lost the function of iodine uptake in radioiodine therapy; (2) Patients received single radioiodine therapy (>= 3.7 GBq [>= 100 MCI]) within 12 months, and the disease progression of the target focus was observed; (3) The interval between two times of radioiodine treatment is less than 12 months, dose >= 3.7 GBq [>= 100mci], disease progression more than 12 months after at least one iodine treatment; (4) The cumulative dose of radioiodine >= 22.2 GBq (>= 600 MCI); 6. The objects with normal functions of main organs meet the following standards: (1) The blood routine examination standard should be in accordance with (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): HB >= 90 g/L ANC >= 1.5 x 10^9/L PLT >= 80 x 10^9/L (2) Biochemical examination shall meet the following standards: TBIL= 50ml / min (Cockcroft Gault formula). 7. Women of childbearing age must have taken reliable contraceptive measures or carried out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, it is necessary to agree to use appropriate methods of contraception or sterilization after operation during the trial period and 8 weeks after the last administration of the test drug; 8. The subjects volunteered to join the study and signed the informed consent form, with good compliance and follow-up cooperation.ye
Exclusion criteria
Exclusion criteria: 1. Patients with non squamous carcinoma (including squamous carcinoma mixed with other pathological tissue types) and nasopharyngeal carcinoma; 2. Patients with active brain metastasis, cancerous meningitis, spinal cord compression, or diseases of brain or pia mater found by imaging CT or MRI during screening (patients with brain metastasis who have completed treatment and have stable symptoms 21 days before randomization can be included in the group, but without cerebral hemorrhage after brain MRI, CT or intravenous imaging evaluation); 3. Patients who have used vegfr-tki small molecule drugs such as vandetanib, cabotinib, lovatinib, sunitinib and sorafenib within one month; 4. Patients with hypertension who cannot be reduced to normal range (systolic blood pressure > 140 mmHg / diastolic blood pressure > 90 mmHg), coronary heart disease >= grade II, arrhythmia (including QTc interval >= 450 ms for men and 470 MS for women); according to NYHA standard, patients with grade III-IV cardiac dysfunction, or patients with left ventricular ejection fraction (LVEF) 1.0g); 8. Patients with obvious cough blood or hemoptysis of 2.5ml or more per day within 2 months before inclusion; 9. The patients with abnormal coagulation (INR > 1.5, APTT > 1.5 ULN) had bleeding tendency, or had arteriovenous thrombosis events within 12 months; 10. The patients with active bleeding, ulcer, intestinal perforation, intestinal obstruction and operation within 28 days before screening (if the operation is performed outside 28 days, the wound must be completely recovered); 11. Patients who have a history of psychoactive drug abuse and are unable to give up or have mental disorders; 12. According to the judgment of the researcher, there are other patients with serious hazards to the safety of patients or accompanying diseases that affect the completion of the study; 13. Patients with central nervous system metastasis; 14. Pregnant or lactating women; 15. Situations that the researchers think are not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tg year-on-year decline rate;Year-on-year reduction rate of target lesions;OS;PFS;DOR;DCR;QoL;safety; | — |
Countries
China
Contacts
Public ContactLiu Shanting
He'nan Cancer Hospital
Outcome results
None listed