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Prospective, multicenter, randomized study on combined LT4 + LT3 therapy versus LT4 in the control of TSH in patients with advanced thyroid cancer treated with tyrosine kinase inhibitors.
EU CTIS ID: 2026-526113-28-00
What this study is testing
Evaluate the efficacy of LT4 + LT3 combination therapy compared with LT4 monotherapy in controlling TSH in patients with advanced thyroid cancer after the initiation of systemic therapy with TKIs.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 and <80 years.
- Patients with a diagnosis of locally advanced/metastatic progressive thyroid cancer, on LT4 therapy, eligible for TKI treatment.
- Circulating TSH levels between 0.1 and 4 mIU/L.
- ECOG performance status ≤2, with no sudden deterioration in the two weeks prior to the start of the study.
- Patients able to understand the full nature and purpose of the study, including potential risks and side effects, able to comply with study procedures, and meet all study requirements according to the investigator’s judgment.
You likely can't join if
- Pregnancy or breastfeeding.
- Hypersensitivity to the investigational medicinal product or its excipients.
- Participation in other clinical studies.
- Use of drugs interfering with peripheral thyroid hormone metabolism or known type 2 deiodinase inhibitors (e.g., amiodarone, propranolol, corticosteroids) and psychotropic medications.
- Clinically significant active malabsorption syndrome or other conditions affecting gastrointestinal drug absorption.
- Symptomatic primary central nervous system tumor or symptomatic CNS metastases.
See the full eligibility criteria
- Age ≥18 and <80 years.
- Patients with a diagnosis of locally advanced/metastatic progressive thyroid cancer, on LT4 therapy, eligible for TKI treatment.
- Circulating TSH levels between 0.1 and 4 mIU/L.
- ECOG performance status ≤2, with no sudden deterioration in the two weeks prior to the start of the study.
- Patients able to understand the full nature and purpose of the study, including potential risks and side effects, able to comply with study procedures, and meet all study requirements according to the investigator’s judgment.
- Pregnancy or breastfeeding.
- Hypersensitivity to the investigational medicinal product or its excipients.
- Participation in other clinical studies.
- Use of drugs interfering with peripheral thyroid hormone metabolism or known type 2 deiodinase inhibitors (e.g., amiodarone, propranolol, corticosteroids) and psychotropic medications.
- Clinically significant active malabsorption syndrome or other conditions affecting gastrointestinal drug absorption.
- Symptomatic primary central nervous system tumor or symptomatic CNS metastases.
- Psychiatric diagnosis of mood disorder or other known psychiatric conditions.
- Treatment with psychotropic drugs, anxiolytics, or mood stabilizers.
- Clinically significant active cardiovascular disease (e.g., NYHA class III/IV heart failure) or history of myocardial infarction.
- Uncontrolled atrial fibrillation or clinically significant arrhythmias in the past 6 months.
- Epatic insufficiency (total bilirubin >2.0 mg/dL, albumin <3.5 g/dL, INR >1.7, ascites, portosystemic encephalopathy) and/or renal insufficiency (eGFR <30 mL/min).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.