Predictive Factors of Long-term Survivor (LTS) of Patients With Recurrent or Metastatic, Radio-iodine Resistant Differentiated Thyroid Cancer (RRDTC) After Lenvatinib: a Multicenter Study

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

65 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is an observational, pharmacological, retrospective, multicenter study and involves a total of 4 enrolling centers. This study aims to demonstrate that, in real-world clinical practice, the survival of RAI-refractory patients treated with Lenvatinib is significantly greater than the 30 months described by Gianoukakis et al., reaching-and in some cases exceeding-5 years.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Adult patients (≥ 18 years of age)
• Patients capable of providing informed consent
• Patients with a diagnosis of differentiated thyroid carcinoma confirmed by cytological or histological examination, showing disease progression within the last 12 months
• Patients with radioiodine-refractory differentiated thyroid carcinoma (i.e., patients with one or more metastatic lesions without RAI uptake; patients with progressive lesions lacking RAI uptake within the last 12 months; or patients who have received a cumulative RAI dose \> 600 mCi)
• ECOG performance status of 0-2
• Patients who are treatment-naïve or with disease recurrence following first-line therapy
• Patients with blood pressure ≤ 150/90 mmHg and adequate bone marrow, liver, and renal function (creatinine clearance \> 30 mL/min calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

• Patients with medullary or anaplastic thyroid carcinoma
• Patients with impaired renal function or proteinuria (urinary protein \>1 g/24 h)
• Patients with a positive medical history of congestive heart failure, unstable angina, ischemic heart disease, ischemic stroke, or cardiac arrhythmias in the last 6 months
• Patients with a prolonged QT interval on pre-treatment ECG
• Patients previously treated with Lenvatinib

Study population

Patients with recurrent or metastatic, radio-iodine resistant differentiated thyroid cancer (RRDTC) treated with Lenvatinib

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

IRCCS San Raffaele

Study start

2026-12 Estimated

Primary completion

2026-12 Estimated

Study completion

2027-06 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts