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.
Key facts
- Where
- Catania, Milan, Naples, Padova, Pavia, Perugia, Pisa, Rome, Salerno és Siena, OlaszországSee the 11 sites
- Phase
- 4. fázis
Where in Olaszország
- ARNAS Garibaldi Di CataniaCatania, OlaszországToborzás még nem indult
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, OlaszországToborzás még nem indult
- Istituto Oncologico VenetoPadova, OlaszországToborzás még nem indult
- 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. SbPavia, OlaszországToborzás még nem indult
- Azienda Ospedaliera di PerugiaPerugia, OlaszországToborzás még nem indult
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországToborzás még nem indult
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, OlaszországToborzás még nem indult
- Azienda Ospedaliero Universitaria SeneseSiena, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ceinge Biotecnologie Avanzate Franco Salvatore S.c.a.r.l.
- Trial code
- EU 2026-526113-28-00
- Record updated
- 2026. július 6.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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); Pregnancy or breastfeeding; Participation in other clinical studies; Symptomatic primary central nervous system tumor or symptomatic CNS metastases.