Differentiated thyroid cancer
Conditions
Interventions
Therapy group:Surufatinib 300 mg, oral taken once daily for 4 weeks
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Histopathological or cytological diagnosis of differentiated thyroid cancer (DTC), including papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma; 3. Radioiodine-refractory differentiated thyroid cancer patients (RR-DTC); 4. Previous treatment with only one tyrosine kinase inhibitor (sorafenib, Lenvatinib or anlotinib) and disease progression; 5. ECOG score 0-1; 6. Expected survival >= 3 months; 7. At least one measurable lesion; 8. Major organ function within 7 days before enrollment, Meet the following criteria: (1) Blood routine examination criteria (14 without transfusion): 1) Hemoglobin (Hb) >= 85 g/L; 2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; 3) platelet (PLT) >= 80 x 10^9/L; (2) Biochemical tests need to meet the following criteria: 1) Total bilirubin (TBIL) = 60 ml/min; 9. Fully understand the study, voluntary participation, and signed informed consent; 10.Male or female patients of childbearing potential voluntarily used effective contraceptive methods during the study and within 6 months after treatment, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to be of childbearing potential unless they are postmenopausal, have undergone artificial menopause, or have undergone sterilization (e.g., hysterectomy, adnexectomy, or radiation ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Previous use of anti-PD-1 or anti-PD-L1/L2 antibodies or anti-cytotoxic T lymphocyte-associated antigen (CTLA-4) antibodies; 2. Received systemic chemotherapy, any form of external irradiation therapy, and other anti-tumor treatment except tyrosine kinase inhibitors within 3 months before enrollment; 3. Received any surgical or invasive treatment or operation (except intravenous catheterization, puncture and drainage, etc.) within 4 weeks prior to enrollment; 4. The patient currently has hypertension that cannot be controlled by medication and is defined as: systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 90 mmHg; 5. Patients with urinary protein >= 2+ and 24-hour urinary protein level > 1.0 g as indicated by two consecutive urine routine tests; 6. The patient has any current disease or condition that affects absorption of the drug, or the patient cannot take surufatinib orally; 7. Patients with obvious evidence or history of bleeding tendency within 3 months before enrollment (bleeding > 30 mL within 3 months, hematemesis, black feces, hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks) or thromboembolism events (including stroke events and/or transient ischemic attack) within 12 months; 8. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure (NYHA) grade > 2; ventricular arrhythmias requiring medication; ECG showed QTc interval >= 480 ms. 9. Has had other malignant neoplasms in the past 5 years, other than basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 10. Active or uncontrolled severe infection (>= CTC-AE grade 2 infection); 11. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 12. Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to doubt is not suitable for the use of study drugs in patients with a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or make the patients at high risk; 13. According to the judgment of the researcher, the patient has other factors that may affect the study results or lead to the termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory examination, and family or social factors, which will affect the patient's safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(progress-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(objective response rate);DCR(disease control rate);OS(overall survival);Safety; | — |
Countries
China
Contacts
Public ContactChen Libo
Shanghai Sixth People's Hospital
Outcome results
None listed