Differentiated thyroid cancer
Conditions
Interventions
experimental group:anlotinib hydrochloride
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined this study, signed an informed consent form, and had good compliance; 2. Age>=18 years old (when signing the informed consent form); ECOG PS score: 0-2 points; The expected survival period exceeds 3 months; 3. Locally advanced or metastatic differentiated thyroid cancer confirmed by histopathology; At least one measurable lesion (RECIST 1.1); 4. Meet any of the following conditions while meeting the above three conditions: (1) The lesion does not have iodine affinity: under conditions of low iodine diet and sufficient TSH elevation (>=30 mIU/L), RAI scanning confirms that there is no RAI uptake (definition of no iodine uptake: no iodine uptake at the beginning; no iodine uptake at the beginning, no iodine uptake later; partial iodine uptake; progress even with iodine uptake); (2) RAI cumulative dose>=600mCi or 22GBq, with a minimum interval of 3 months between enrollment. (3) Although there is iodine-131 affinity during RAI treatment, radiological examination confirms that disease progression occurs within 18 months after RAI treatment; Note: To determine disease progression, both of the following conditions must be met simultaneously: i. Objective evidence of disease progression within 18 months prior to screening; Ii The disease progression or recurrence occurred 18 months after the last iodine treatment. (4) Locally advanced thyroid cancer: i. Thyroid cancer with extensive disease and multiple organ involvement that cannot be removed Ii. Thyroid cancer and/or local metastatic lymph nodes that invade at least one structure (trachea, esophagus, larynx, anterior vertebral fascia, brachial plexus) or surround at least one blood vessel (common carotid artery, mediastinal vessel) may not be able to achieve R0/R1 resection based on CT evaluation (5) After surgery and iodine 131, there are still suspicious and evaluable lesions in imaging or hematological indicators that do not reach the ideal range [Under TSH stimulation and TG-ab negative conditions, Tg is greater than 10] 6. The main organ function shall meet the following standards within 7 days before treatment: (1) Blood routine examination standard (without blood transfusion within 14 days): 1) Hemoglobin (Hb)>=85g/L; 2) Absolute value of neutrophils (ANC)>=1.5 × 109/L; 3) Platelets (PLT)>=80 × 109/L; (2) Biochemical examination must meet the following standards: 4) Total bilirubin (TBIL)=60ml/min; 7. Female patients of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days before enrollment, the serum pregnancy test was negative and must be a non lactating patient; Male patients should agree to use contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Has experienced or currently suffers from other malignant tumors within 3 years; 2. Within 28 days prior to the start of research treatment, significant surgical treatment, open biopsy, or obvious traumatic injury was received; 3. Subjects with any severe and/or uncontrollable diseases, including: 1) Suffering from>=2-grade myocardial ischemia or infarction, arrhythmia (including male QTc>=450ms (male), QTc>=470ms (female)), and>=2-grade congestive heart failure (New York Heart Association (NYHA) classification); 2) Active or uncontrollable severe infections (>=CTC AE level 2 infection); 3) Renal failure requiring hemodialysis or peritoneal dialysis; 4. According to the judgment of the researcher, patients with accompanying diseases that seriously endanger patient safety or affect the completion of the study, or patients who believe that there are other reasons that are not suitable for enrollment. 5. Patients who have previously used amlotinib hydrochloride capsules or similar VEGFR-TKI small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, sorafenib, etc. for treatment; 6. Patients who have received external radiation therapy or iodine-131 therapy within the past 3 months, or plan to undergo systemic anti-tumor therapy during the medication period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or have used mitomycin C within 6 weeks before receiving experimental drug treatment), cannot use traditional Chinese medicine for anti-tumor treatment at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR (pathologic Complete Response);ORR(objective response rate);PFS(progression-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(disease control rate);DOR(Duration of response);OS(Overall survival);Incidence and severity of adverse events (AE).; | — |
Countries
China
Contacts
Public ContactXiaowei Qi
The First Affiliated Hospital of Army Military Medical University
Outcome results
None listed