Thyroid cancer
Conditions
Interventions
one:Apatinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male or female; 2. locally advanced differentiated thyroid carcinomas (papillary, follicular, Hurthle, poorly differentiated); 3. Primary differentiated thyroid cancer ,without surgery , chemotherapy and radiotherapy or other therapy; 4. stage T3b or T4 on imaging or cardiopulmonary insufficiency with surgery or with high risk of recurrence and metastasis; 5. There is at least one measurable lesion to be treated according the RECIST 1.1; 6. the main organ function is normal, meet the following requirements: routine blood test should be consistent (14 days without blood transfusion): HB = 90g/L); ANC = 1.5 * 109/L; PLT = 80*10^9/L; Biochemical tests should meet the following criteria: BIL <1.5 times normal value limit (ULN); ALT and AST<2.5 * ULN; serum Cr, creatinine clearance rate was higher than 60ml/min (Cockcroft-Gault formula); 7. ECOG PS 0-2 points; 8. women of childbearing age must have pregnancy tests (serum or urine) within 7 days before admission to the group. The result is negative and voluntary. During the observation period and 8 weeks of the last given apatinib after using appropriate contraceptive methods; for men, should be hand Surgical sterilization, or consent during the observation period, and the last piece of apatinib given appropriate methods within 8 weeks after using contraception; 9. patients voluntarily entered the study and signed informed consent (ICF).;Inclusion criteria: 1. Aged 18 to 75 years old male or female; 2. locally advanced differentiated thyroid carcinomas (papillary, follicular, Hurthle, poorly differentiated); 3. Primary differentiated thyroid cancer ,without surgery , chemotherapy and radiotherapy or other therapy; 4. stage T3b or T4 on imaging or cardiopulmonary insufficiency with surgery or with high risk of recurrence and metastasis; 5. There is at least one measurable lesion to be treated according the RECIST 1.1; 6. the main organ function is normal, meet the following requirements: routine blood test should be consistent (14 days without blood transfusion): HB = 90g/L); ANC = 1.5 * 109/L; PLT = 80*10^9/L; Biochemical tests should meet the following criteria: BIL <1.5 times normal value limit (ULN); ALT and AST<2.5 * ULN; serum Cr, creatinine clearance rate was higher than 60ml/min (Cockcroft-Gault formula); 7. ECOG PS 0-2 points; 8. women of childbearing age must have pregnancy tests (serum or urine) within 7 days before admission to the group. The result is negative and voluntary. During the observation period and 8 weeks of the last given apatinib after using appropriate contraceptive methods; for men, should be hand Surgical sterilization, or consent during the observation period, and the last piece of apatinib given appropriate methods within 8 weeks after using contraception; 9. patients voluntarily entered the study and signed informed consent (ICF).
Exclusion criteria
Exclusion criteria: 1. differentiated histologic subtypes of other thyroid carcinomas (e.g., medullary carcinoma, lymphoma, or sarcoma); 2. have experience of other new drug clinical trials 3. Allergy to the drug in this protocol 4. Active or uncontrolled severe infection or other severe and /or uncontrolled diseases 5. with Long-term healed wounds 6. hypertension, antihypertensive drugs can not be reduced to the normal range (systolic / diastolic blood pressure of >90 >140 mmHg mmHg), suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation of male >450 MS, female >470 MS) and heart failure; 7. many factors that influence the absorption of oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction 8. abnormal coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN), with bleeding tendency( eg , ulcers, Fecal occult blood>2+, or Within 30 days after surgery) 9. History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform 10. History of other malignancies within the last 5 years except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix; 11. other physicians considered unsuitable for inclusion. ;Exclusion criteria: 1. differentiated histologic subtypes of other thyroid carcinomas (e.g., medullary carcinoma, lymphoma, or sarcoma); 2. have experience of other new drug clinical trials 3. Allergy to the drug in this protocol 4. Active or uncontrolled severe infection or other severe and /or uncontrolled diseases 5. with Long-term healed wounds 6. hypertension, antihypertensive drugs can not be reduced to the normal range (systolic / diastolic blood pressure of >90 >140 mmHg mmHg), suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation of male >450 MS, female >470 MS) and heart failure; 7. many factors that influence the absorption of oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction 8. abnormal coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN), with bleeding tendency( eg , ulcers, Fecal occult blood>2+, or Within 30 days after surgery) 9. History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform 10. History of other malignancies within the last 5 years except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix; 11. other physicians considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of R0 surgery;changing situation of serum Tg;Disease-free survival;the safety;;Rate of R0 surgery;changing situation of serum Tg;Disease-free survival;the safety; | — |
Countries
China
Contacts
Public ContactWang Zhuoying;Wang Zhuoying ;
Fudan University Shanghai Cancer Center ;Fudan University Shanghai Cancer Center
Outcome results
None listed