Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

Trial Title: Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

NCT ID: NCT06405217

Condition: DTC - Differentiated Thyroid Cancer
Thyroid Stimulating; Hormone, C
Radiotherapy; Complications

Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Hormones

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Recombinant Human Thyroid Stimulating Hormone
Description: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days
Arm group label: Recombinant human thyroid stimulating hormone group

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Nanjing First Hospital

Address:
City: Nanjing
Zip: 210006
Country: China

Status: Recruiting

Contact:
Last name: Feng Wang, Ph.D.

Phone: 86-025-52271455
Email: fengwangcn@hotmail.com

Start date: April 20, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Nanjing First Hospital, Nanjing Medical University
Agency class: Other

Source: Nanjing First Hospital, Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06405217