Thyroid Cancer
Conditions
Interventions
Neoadjuvant therapy group:Lenvatinib combined with epirubicin
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient is aged 18 or above and less than 70 years; 2. Histopathologically confirmed differentiated thyroid cancer; 3. Locally advanced stage I/II/III/IV primary DTC; 4. Multiple swollen and fused lymph nodes evaluated by physical examination and imaging examination, and compression of surrounding tissues, blood vessels, and nerves; 5. Eastern Cooperative Oncology Group (ECOG) score of 0-2 points; 6. Have fully understood the study and voluntarily signed the ICF; 7. No history of anti-tumor therapy before treatment; 8. Laboratory test values ??must meet the standards within 7 days before enrollment; 9. Within 21 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 60 days after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Have a history of thyroid tumors and surgery for thyroid diseases; 2. Patients who have previously received systemic therapy based on doxorubicin, tyrosinase inhibitors, and targeted therapy; 3. Has a history of treatment for malignant tumors within the past 5 years; 4. Patients with symptoms of active central nervous system (CNS) metastasis and/or cancerous meningitis, or uncontrollable major epilepsy, unless excluded by CT or MRI examination; 5. Have any active autoimmune disease or history of autoimmune disease; 6. Known clinically significant liver disease; 7. Uncontrolled pleural effusion, pericardial effusion, or more than moderate ascites; 8. Significant cardiovascular disease, such as heart disease (Class II or higher) as defined by the New York College of Cardiology; 9. Myocardial infarction, unstable arrhythmia, and unstable angina occurred within 3 months before enrollment; 10. Any significant clinical and laboratory abnormalities that the researchers believe will affect the safety evaluators, such as: uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to the following range after monotherapy (Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg), grade II or above peripheral neuropathy, congestive heart failure, chronic kidney disease; 11. Pregnant or lactating female patients, or those who are unwilling to use contraception during the trial; 12. Patients with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 13. Active infection, or received oral or intravenous antibiotic treatment within 2 weeks before enrollment, except for preventive medication; 14. Received other experimental drug treatment or participated in clinical research for other therapeutic purposes within 28 days before enrollment; 15. Any other diseases, metabolic disorders, abnormal results of physical examination or laboratory examinations, and there is reason to suspect that the use of experimental drugs may be contraindicated, or affect the reliability of research results, or put patients at high risk of treatment complications , or affect patient compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size;Do not share raw data;Operation r0 resection rate;Objective remission rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate; | — |
Countries
China
Contacts
Public ContactBao Guoqiang
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed