Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called recombinant human thyroid stimulating hormone (rhTSH) to see if it can help improve the diagnosis of locally advanced or metastatic differentiated thyroid cancer. This treatment aims to safely increase thyroid-stimulating hormone levels for a short period, allowing doctors to perform better scans using radioactive iodine (131I) before and after patients receive another type of treatment called antiangiogenic tyrosine kinase inhibitors (TKIs). By using rhTSH, the trial hopes to reduce the side effects related to stopping thyroid hormone and to better understand how the TKIs affect the cancer.

To qualify for this trial, participants must be between 18 and 75 years old, have a specific type of thyroid cancer that has come back or spread, and have at least one measurable tumor. They should also be in relatively good health, with certain blood counts and organ functions meeting the study's requirements. Participants can expect to receive rhTSH and undergo scans to monitor their condition. It’s important for potential participants to discuss this opportunity with their healthcare provider to understand if it's the right fit for them.

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 (tg), 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;
• • Patients diagnosed with iodine-refractory/potentially iodine-refractory DTC after multidisciplinary team discussion.
• Exclusion Criteria:
• • Accompanied by pleural effusion or ascites, causing respiratory distress;
• • Symptoms of brain metastasis cannot be controlled and treated in less than 2 months; there is a risk of suffocation due to excessively large neck metastatic masses; patients with spinal bone metastases have a risk of spinal cord compression paralysis; cardiac metastasis, heart failure, and patients at risk of acute cardiovascular events;
• • 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 (QTc) male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association (NYHA) 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 (HCV) 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 (rhTSH 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.

Trial Officials