Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with differentiated thyroid cancer (DTC) who have had surgery but are experiencing recurring or spreading cancer. Researchers want to compare the effects of a special injection of recombinant human thyroid stimulating hormone (TSH) given for two days with a traditional method that involves stopping thyroid hormone treatment for several weeks before receiving a radioactive treatment called radioiodine (131I). The goal is to see which method helps the patients better manage their cancer and what side effects might occur.

To participate in the trial, patients should be between 18 and 75 years old, have a specific type of thyroid cancer that has been confirmed by medical tests, and have at least one measurable tumor. Other health requirements include having stable blood counts and kidney function. Participants will receive radioiodine treatment after their TSH levels are raised to a certain point and will be monitored closely for the effectiveness of the treatment and any potential side effects. It's important for potential participants to understand that they need to follow specific health and safety guidelines throughout the study, including using contraception if they are of childbearing age.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
• • Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up.
• Exclusion Criteria:
• • 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;
• • Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;
• • Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;
• • Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;
• • Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;
• • Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.