Thyroid cancer
Conditions
Interventions
Case series:Anlotinib Capsules
Sponsors
Tianjin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent; 2. Patients who were not suitable to received surgery, included locally advanced differentiated thyroid carcinoma (DTC) or medullary thyroid carcinoma (MTC), according to histopathological diagnosis, patients who were not suitable to received surgery defined as: (1) Patients with the huge tumor , which invaded the surrounding organs and tissues, were not suitable for surgery; (2) Patients with high riskof relapse after surgery coule also be recruited; (3) Patients coule also be recruited if tumor shrinkage may avoid damage to the healthy tissue; (4) Patients coule also be recruited if the tumor were adjacent to major blood vessels, esophagus,trachea and other orgens; Notes:Patients with metastases were eligible to participate in the study, patients with recurrent disease were eligible to participate in the study, TNM stage of the patients included: (1) DTC patients with T4, any N, and any M stage according to AJCC TNM; (2) DTC patients with any T, N1, and any M stage according to AJCC TNM; (3) MTC patients with T4, any N, and M0 stage according to AJCC TNM; (4) MTC patients with any T, N1, and M0 stage according to AJCC TNM; 3. At least one measurable lesion (RECIST 1.1); 4. Aged 18 to 75 years old, ECOG PS0-2, Expected Survival Time: Over 6 months; 5. Major organ functions meet the following criteria within 7 days before treatment: (1) Blood routine examination standard (under the condition of no blood transfusion within 14 days): Hemoglobin (HB)=100g/L, absolute Neutrophil Count (ANC)=1.5 x 10^9/L, platelets (PLT)=80 x 10^9/L, the biochemical; (2) Inspection must meet the following standards:total bilirubin (TBIL) = 1.5 upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase AST=2.5ULN, such as liver metastasis, ALT and AST=5ULN, serum creatinine (Cr) = 1.5ULN and creatinine clearance (CCr) = 60ml/min; (3) Cardiac ultrasoundLVEF = 1.5 x lower limit of normal(50%); 6. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion criteria
Exclusion criteria: 1. Previously use of Anlotinib Hydrochloride or other anti- angiogenesis agents, such as Vandetanib, Cabozantinib, Lenvatinib, Sunitinib, Sorafenib, Bevacizumab. and RET inhibitors such as LOXO-292, Blu-667; 2. Patients who have received iodine-131 ablation or other local anti-tumor therapy within the last 3 months, or who plan to receive systemic anti-tumor therapy or external irradiation or other interventional therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, during the study period (or who have received mitomycin C within 6 weeks prior to receiving experimental drug). Treatment with levothyroxine for TSH suppression and thyroxine supplementation is permitted. During the study period, Chinese medicines should not be used during the treatment; 3. Patients who have developed or are currently suffering from other malignancies within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invasion of basal membrane)], or who have undergone solid organ and bone marrow transplantation; 4. Patients with unmitigated toxic reactions (excluding alopecia) of Grade 1 above CTC AE (5.0) due to any prior treatment; 5. With kinds of factors which affect oral medicine (e.g. failing to swallow); 6. Patients with respiratory syndrome caused by pleural effusion or ascites (=CTC AE Grade 2 dyspnea [Grade 2 dyspnea refers to shortness of breath during a small amount of activity, affecting instrumental activities of daily living]); 7. Serious illness or medical condition(s) including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg) after taking 1-2 antihypertensive drugs; (2) Patients who have suffered significant cardiovascular impairment, including but not limited to: = Grade II congestive heart failure (New York Heart Association (NYHA) classification), unstable angina pectoris, myocardial infarction, ischemic cardiomyopathy or stroke within 6 months prior to the first dose; (3) Patients with sinus bradycardia of Grade 1 or above (CTCAE 5.0), or atrioventricular block of second degree or above, or sinus arrest (except for those with a pacemaker), arrhythmias (including QTC =480ms), requiring the use of drugs known to prolong QTC interval, including antiarrhythmic therapy; (4) Active or uncontrolled clinically serious infection(=CTC AE grade 2); (5) Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; (6) Renal failure requires hemodialysis or peritoneal dialysis; (7) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8) Uncontrolled diabetes(FBG)>10mmol/L); (9) Urinary protein quantitative value=++and quantitative protein is >1.0g in a 24 hour urine sample; 8. Take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping; 9. Patients with imaging findings showing tumor invasion of vital blood vessels or with a high likelihood of tumor invasion of vital blood vessels resulting in fatal bleeding during the follow-up study as determined by the investigator. 10. Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Actual operation rate;R0 removal rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of local lesions;Time to Response;DCR;3-year LRFS;5-year LRFS;PFS;Quality of Life; | — |
Countries
China
Contacts
Public ContactHao Jie
Tianjin People's Hospital
Outcome results
None listed