poorly differentiated thyroid carcinoma and anaplastic thyroid carcinoma
Conditions
Interventions
treatment group:Taking medicine
Sponsors
Department of Thyroid Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. It is initially diagnosed as poorly differentiated thyroid carcinoma or undifferentiated thyroid carcinoma confirmed by histopathology; 2. Male or female patients aged = 18 years and = 75 years 3. ECOG score: 0-1 (ECOG physical strength scoring standard); The expected survival time is more than 3 months; 4. Fail to perform R0/R1 resection (definition of R0 resection: complete resection, all margins are negative; definition of R1 resection: incomplete tumor resection with positive margins under microscope; definition of fail to perform R0/R1 resection: extensive tracheal invasion, carotid artery invasion, pre vertebral fascia invasion, etc.); 5. According to the RECIST 1.1 standard, it has measurable lesions; 6. Have not received any anti-tumor treatment before enrollment; 7. If the main organs function normally, they meet the following standards: 1) The blood routine examination standard should meet (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulators were used to correct): a. HB (hemoglobin) = 90 g/L; b. ANC = 1.5 × 109/L c. PLT = 80 × 109/L 2) Biochemical examination shall meet the following standards: a. TBIL45 ml/min (Cockcroft Gault formula); 3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%). 8. Non surgical sterilization female patients of childbearing age must have negative serum or urine HCG test results within 7 days before enrollment in the study, and be willing to use appropriate methods of contraception during the test period and within 3 months after the last administration of the test drug. For men, they must be patients who agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the trial drug or who have been surgically sterilized; 9. Sign the informed consent form (or signed by the legal representative) to prove that they understand the purpose of the study and the operation required by the study, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing radical thyroidectomy again; 2. The patient is participating in other clinical studies or less than 4 weeks after the completion of the treatment in the previous clinical study; 3. Other diseases requiring surgical treatment; 4. The tumor involves major blood vessels; 5. Have had or currently have other active malignant tumors within 5 years; Patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ who have undergone potentially curable treatment and are free of disease recurrence within 5 years of the start of treatment are excluded; 6. A history of continuous systemic corticosteroid treatment within the past 1 month; 7. Uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg despite optimal medication); 8. Unalleviated toxicity above CTCAE grade 1 due to any prior treatment, excluding hair loss; 9. Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT & GT; 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: The use of low-dose heparin (60 000 ~ 12 000 U per day for adults) or low-dose aspirin (100 mg or less per day) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) =1.5. 10. Renal insufficiency: urine protein = ++ indicated by routine urine examination, or confirmed 24-hour urine protein level =1.0g; 11. Underwent surgery within 28 days prior to enrollment; 12. Patients with grade 3 or above pleural effusion or pneumothorax according to NCI-CTCAE 4.03 grading standard; 13. Severe acute or chronic infections requiring systemic treatment; 14. Severe cardiovascular disease: grade ? or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms for men and =470 ms for women); Patients with grade ? ~ ? cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) 10mmol/L); 17. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc. 18. Had clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as respiratory tract bleeding, digestive tract bleeding, hemorrhagic gastric ulcer, fecal occultic blood ++ or above at baseline, or had vasculitis, etc. 19. Untreated active hepatitis (hepatitis b: HBsAg positive with HBV DNA= 500IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Co-infection with hepatitis B and c; 20. There were arteriovenous/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., within 6 months before enrollment; 21. Patients with tumor plug; 22. Patients who have a history of psychotropic drug abuse and are unable to quit or suffer from uncontrollable neurological, psychiatric or mental disorders, poor compliance, and are unable to cooperate and describe treatment responses; 23. In the judgment of the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RO/R1 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate, ORR;Disease control rate, DCR;Dissease free survival, DFS;Progression Free Survival, PFS;1 year Overall survival Rate, 1y OSR; | — |
Countries
China
Contacts
Public ContactWei Tao
West China hospital, Sichuan University
Outcome results
None listed