Thyroid cancer
Conditions
Interventions
Experimental group:Surufatinib + seed implantation
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and sign the informed consent voluntarily; 2. Aged >= 18 years (calculated on the day of signing informed consent), both male and female; 3. Advanced iodine-refractory differentiated thyroid cancer (including papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma and other variants) diagnosed by histology or cytology for the first or retreatment, the tumor is locally advanced and / or distant metastasis, cannot or do not agree to undergo surgical resection, radiotherapy, or targeted drug therapy again; 4. The patient must have at least one measurable lesion (RECIST 1.1); 5. The TSH level of DTC patients before enrollment should be at least =600mCi or the equivalent dose level, and the patient must have disease progression confirmed by imaging within 14 months before the start of study drug treatment. 7. ECOG physical condition 0-2 points; 8. Expected survival >= 12 weeks; 9. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within 14 days before enrollment is not allowed): (1) Blood routine: white blood cells >= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; (2) International Normalized Ratio (INR) =50% detected by two-dimensional echocardiography. 10. Male or female patients with reproductive potential voluntarily use effective contraceptive methods during the study period and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (eg, hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Have received approved or under research systematic anti-tumor treatment within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, traditional Chinese medicine treatment (traditional Chinese medicine treatment with clear anti-tumor indications in the instructions can also be enrolled after 4 weeks of washout period); 2. Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment; 3. Have received any operation or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.); 4. The subject has suffered from other malignant tumors in the past or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ (DCIS), and other malignant tumors that have been fully treated and cured for >= 5 years and have evidence of no recurrence and metastasis before enrollment; 5. Clinically significant electrolyte abnormalities judged by the researcher; 6. The patient currently has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure >= 150 mmHg and / or diastolic blood pressure >= 90 mmHg; 7. The patient currently has any disease or state that affects drug absorption, or the patient cannot take sufantinib orally; 8. The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcer and ulcerative colitis, or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researcher; 9. Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment (bleeding > 30 ml within 3 months, hematemesis, black stool and bloody stool), hemoptysis (fresh blood > 5 ml within 4 weeks) or thromboembolism events (including stroke events and / or transient ischemic attack) within 12 months; 10. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; Ventricular arrhythmias requiring drug treatment; ECG showed QTc interval >= 480ms; 11. Active or uncontrolled severe infection (>= CTCAE grade 2 infection); 12. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [known as hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e. HBV DNA positive (> 1 x 10^4 copies / ml or > 2000 IU / ml); known hepatitis C virus infection (HCV) and HCV RNA positive (> 1 x 103 copies / ml), or other hepatitis, cirrhosis]; 13. The patient has central nervous system (CNS) metastasis or previous brain metastasis; 14. Unrelieved toxic reactions above CTCAE level 1 caused by any previous anti-cancer treatment, excluding hair loss, lymphopenia and neurotoxicity <= Level 2 caused by oxaliplatin; 15. Pregnant (positive pregnancy test before medication) or lactating women; 16. Received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days before enrollment; 17. Imaging shows that the tum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;disease control rate;Safty; | — |
Countries
China
Contacts
Public ContactShi Feng
Hunan Cancer Hospital
Outcome results
None listed