2026-526113-28-00Not yet recruitingPhase 4
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- 4 Jan 2027
- Lead sponsor
- Ceinge Biotecnologie Avanzate Franco Salvatore S.c.a.r.l.
- Diseases
- Thyroid cancer
- EU CT number
- 2026-526113-28-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced thyroid cancer who take LT4 and can start a TKI drug. It compares LT4 + LT3 with LT4 alone for controlling TSH.
- Age
- From 18 years to under 80 years.
- Sex
- All sexes can join.
- Disease stage
- Thyroid cancer that is locally advanced or has spread, and is getting worse. ECOG performance status of 2 or lower, with no sudden decline in the 2 weeks before the start.
- Earlier treatment
- Must already be on LT4 therapy. Must be able to have treatment with a TKI drug.
- Biomarker or test result
- TSH level in the blood between 0.1 and 4 mIU/L.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Taking part in another clinical study
- Symptomatic brain tumor or symptomatic cancer spread to the brain
- Serious active heart disease, a past heart attack, or uncontrolled atrial fibrillation or serious rhythm problems in the past 6 months
- Serious liver failure or kidney failure (eGFR below 30 mL/min)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of drugs interfering with peripheral thyroid hormone metabolism or known type 2 deiodinase inhibitors (e.g., amiodarone, propranolol, corticosteroids) and psychotropic medications.
- Treatment with psychotropic drugs, anxiolytics, or mood stabilizers.
Other illness
- Hypersensitivity to the investigational medicinal product or its excipients.
- Clinically significant active malabsorption syndrome or other conditions affecting gastrointestinal drug absorption.
- Psychiatric diagnosis of mood disorder or other known psychiatric conditions.
- 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.
Lab values
- 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).
Other
- Pregnancy or breastfeeding.
- Participation in other clinical studies.
- Symptomatic primary central nervous system tumor or symptomatic CNS metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ARNAS Garibaldi Di Catania | Catania | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples | Italy | Not yet recruiting |
| Istituto Oncologico Veneto | Padova | Italy | Not yet recruiting |
| Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb | Pavia | Italy | Not yet recruiting |
| Azienda Ospedaliera di Perugia | Perugia | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona | Salerno | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Senese | Siena | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.