Differentiated thyroid cancer
Conditions
Interventions
Experimental group:Anlotinib Sequential Iodine-131 Therapy
Sponsors
Shanghai 6th People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in research and sign informed consent, with good compliance; 2. At the time of signing the informed consent, aged between 18 and 70 years(both 18 and 70), no gender limits; 3. Locally advanced or metastatic differentiated thyroid cancer patients with clear history and confirmed by imaging or pathology; 4. The presence of RECIST measurable lesions (CT, MRI, FDG-PET / CT, etc.); 5. ECOG score was 0-1, and the expected survival time was more than 24 weeks; 6. At baseline, the basic laboratory examination met the following criteria: (1) Blood routine: HB >= 90g / L (no blood transfusion or EPO dependence within 14 days); ANC >= 1.5 x 10^9 / L, PLT >= 80 x 10^9 / L; (2) Blood biochemistry: TBIL = 60ml / min (Cockcroft Gault formula); (4) Routine urine examination: urine protein = lower limit of normal value (50%). 7. At the time of screening, the blood pregnancy test results of women of childbearing age (such as those who have not undergone surgical sterilization or who have been postmenopausal for less than one year) were negative; Men and women of childbearing age agreed to take effective contraceptive measures within 6 months after signing the informed consent form and were not allowed to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. The past 5 years had other malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ; 2. The contraindications were treated with iodine-131, such as positive pregnancy test, lactation and so on; 3. TKI was used to treat tumor; 4. It is not expected to benefit from the next iodine-131 treatment; 5. Patients with hypertension and were unable to get good control (systolic pressure > 150 mmhg, diastolic pressure > 100mmhg) after two antihypertensive drugs; 6. The significant cardiovascular and cerebrovascular damage includes but is not limited to the NYHA grade >= grade II congestive heart failure or coronary heart disease, and with an uncontrollable history of unstable angina, myocardial infarction or ischemic cardiomyopathy, and has been screened for stroke within the first six months; 7. The patients with above grade 1 sinus bradycardia (CTCAE 5.0), or more than two degrees of atrioventricular block or sinus arrest (except for those with pacemakers installed); 8. Arrhythmia (including QTc >= 470 ms) requires simultaneous use of known drugs that can extend QTc interval, including antiarrhythmic therapy; 9. The patients are suffering from active or uncontrollable serious infection (>= CTCAE Level 2 infection); 10. There are many factors that affect the oral and absorption of drugs (such as inability to swallow, nausea and vomiting, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 11. Patients with bleeding tendency (such as active gastrointestinal ulcer) or treated with anticoagulants or vitamin K antagonists such as fawarrin, heparin or similar substances; 12. Imaging showed that tumor had invaded important vascular weeks or was judged by researchers that tumor was likely to invade important vessels and cause fatal bleeding during the follow-up study; 13. The first three months of screening were treated with external radiotherapy or planned to carry out systemic anti-tumor treatment during the study period, including cytotoxic therapy, signal transduction inhibitor and immunotherapy; 14. The anti-tumor treatment of traditional Chinese medicine is planned to be used simultaneously; 15. There are long-term unconnected wounds or fractures; 16. The patients with arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep vein vessels and pulmonary embolism; 17. Patients who have the history of abuse of psychoactive drugs and who cannot be removed or have a history of mental disorder; 18. The researchers believe that there may be situations where the subject may be damaged or the subject is unable to meet or perform the research requirements, or other circumstances that the researchers consider unsuitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Response time;Biochemical response rate;Safety; | — |
Countries
China
Contacts
Public ContactChen Libo
Shanghai Sixth People's Hospital
Outcome results
None listed