differentiated thyroid cancer
Conditions
Interventions
treatment group:donafenib
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, the observed patients agreed to sign the informed consent form for participating in the study; 2. Age: =14 years old, male and female; 3. Locally advanced differentiated thyroid cancer clearly diagnosed by histology/cytology,included papillary thyroid carcinoma and follicular thyroid carcinoma. 4. The definition of locally advanced thyroid cancer meets at least one of the following: T3 or T4a thyroid cancer as defined by AJCC 5. Have not received systematic treatment. 6. At least one evaluable lesion (RECIST 1.1 standard); 7. The physical condition (PS) score of the Eastern Cancer Cooperation Group (ECOG) was 0-1; 8. Expected survival time = 3 months; 9.Female patients of childbearing potential (meaning nonmenopausal or surgical sterilization) must have a negative serum pregnancy test result within 7 days prior to the administration of the study drug; 10. Female or male patients of childbearing potential, must be taken during the study drug use and within 60 days after the last dose11. Child-Pugh score = 7 points; 11. The function of main organs is normal, that is, they meet the following standards: Routine blood test (no blood transfusion and G-CSF used within 14 days before screening): a) Hemoglobin = 90 g/L; b) Absolute neutrophil count (ANC) = 1.5 × 109/L c) Platelet count = 100× 109/L Blood biochemical examination (no albumin was used within 14 days before screening): d) Albumin = 28 g/L; e) Total bilirubin = 1.5× Upper limit of normal value (ULN); f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5 × ULN( patients with liver metastases AST/ALT =5× ULN g) Creatinine = 1.5 × ULN Coagulation function: h) International normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN i) Activated partial thromboplastin time (APTT) = 1.5 × ULN Others: j) Urine protein <2+ (if urine protein = 2+, 24-hour urine protein quantification can be performed, 24-hour urine protein quantification <1.0g can be enrolled)
Exclusion criteria
Exclusion criteria: Previous or comorbid diseases: 1) Combined with other histological subtypes of thyroid cancer other than DTC (such as undifferentiated carcinoma, medullary cancer, lymphoma or sarcoma, etc.); 2) Patients who have undergone radical thyroidectomy again; 3) Have clinical symptoms of central nervous system metastases and/or carcinogenic meningitis, with a history of leptomeningeal carcinoma; 4) Cancer with a different primary site or histological type than thyroid cancer within 5 years before randomization, or cancer that coexists with thyroid cancer but has a different primary site or histological type, exceptions are cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (non-invasive tumors, carcinoma in situ, and tumor invasion of the membrane propria). 5) Previous history of severe psychiatric illness; 6) Have diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); Previous or combined medication/treatment: 7) Had undergone major surgery (as defined by the investigator) within 4 weeks prior to enrollment, or was expected to require major surgery during study treatment; 8) Have received iodine-131 ablation or other anti-tumor local therapy within the past 3 months, or plan systemic anti-tumor therapy or external beam or other interventional treatments during the use of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to receiving the test drug). TSH suppression with levothyroxine and thyroxine supplementation are not prohibited; 9) He has previously received targeted treatment of anti-VEGF and/or VEGFR, RAF, MEK and other signal pathways such as sorafenib, lenvatinib, anlotinib, etc. 10) At the same time, take drugs that may prolong QTc and/or induce torsade de pointe (Tdp) or affect drug metabolism; 11) The patient is known or suspected to have a history of allergy to donafinil or similar drugs, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to the excipients of the study drug; 12) Subjects with clinically uncontrollable pleural effusion/peritoneal effusion, no need to drain effusion, or no significant increase in effusion for 3 days after stopping drainage, can be enrolled; 13)Active bleeding or abnormal coagulation function, bleeding tendency or undergoing thrombolytic, anticoagulant or antiplatelet therapy; 14) History of gastrointestinal bleeding or clear gastrointestinal bleeding tendency within the past 4 weeks (eg: known local active ulcer lesions, fecal occult blood + or more, if persistent fecal occult blood +, gastroscopy should be performed) or other conditions identified by the investigator as likely to cause gastrointestinal bleeding (eg, severe fundus/esophageal varices); 15) Gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within the past 6 months; 16) There have been thrombosis or thromboembolism events in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc; 17) Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery in the past 6 months, congestive heart failure (NYHA grade>2 of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0/R1 resection rate;progression-free survival;Time to response;Disease conotrol rate;3years -local recurrence-free survival;5 years -local recurrence-free survival;adverse event; | — |
Countries
China
Contacts
Public ContactWu Yu
Fujian Cancer Hospital
Outcome results
None listed