Using a hormone injection to improve treatment for thyroid cancer

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer

This study is testing whether hormone injections can help improve treatment outcomes for patients with recurring or spreading thyroid cancer compared to stopping their thyroid hormone for a few weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06405217 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of recombinant human thyroid stimulating hormone (rhTSH) injections in patients with postoperative local recurrent or metastatic differentiated thyroid cancer. Participants are divided into two groups: one receiving rhTSH injections for two consecutive days and the other undergoing thyroid hormone withdrawal for 4-6 weeks. Both groups will subsequently receive radioiodine treatment, and the study aims to evaluate the efficacy and adverse reactions associated with each approach. The trial focuses on patients who have measurable lesions and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic differentiated thyroid cancer who have undergone total or subtotal thyroidectomy.

Not a fit: Patients with other types of thyroid cancer or those who do not meet the health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of radioiodine treatment for patients with differentiated thyroid cancer.

How similar studies have performed: Previous studies have shown promising results using similar hormone stimulation approaches in thyroid cancer treatment.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

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