Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .
Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.
The two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\>30mU/L). The efficacy and adverse reactions were observed.
Age: 18~75 years old (including 18 and 75 years old);
ECOG: 0-2 points;
Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar >10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
Unable to quit or with a history of psychiatric medication abuse;
Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;
Parallel
Recombinant Human Thyroid Stimulating Hormone
DrugRecombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days
The rate of hyroid stimulating hormone elevation
The proportion of patients with thyroid stimulating hormone\>30 mIU/L
Incidence of Treatment-Emergent Adverse Events
This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
Overall response rate
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria (RECIST v1.1 criteria) in Solid Tumors
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