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RECRUITINGINTERVENTIONAL

SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement. The main questions the study will answer are: * What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs? * What clinical or laboratory factors can predict successful withdrawal of levothyroxine? Participants will: * Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine * Have already stopped ICI therapy * Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal * Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg) * Be monitored with thyroid function tests and clinical symptoms at each visit

Who May Be Eligible (Plain English)

Who May Qualify: - Adults aged 19 years or older. - Patients with a history of treatment with immune checkpoint inhibitors (ICIs). - Developed hypothyroidism during ICI treatment and initiated levothyroxine after starting ICI therapy. - Discontinued ICI therapy prior to study enrollment. Who Should NOT Join This Trial: - Use of levothyroxine or antithyroid medications within 3 months prior to initiating ICI therapy. - History of thyroid surgery, radioactive iodine therapy, or neck radiation therapy. - Current levothyroxine dose ≥0.1 mg at the time of enrollment. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults aged 19 years or older. * Patients with a history of treatment with immune checkpoint inhibitors (ICIs). * Developed hypothyroidism during ICI treatment and initiated levothyroxine after starting ICI therapy. * Discontinued ICI therapy prior to study enrollment. Exclusion Criteria: * Use of levothyroxine or antithyroid medications within 3 months prior to initiating ICI therapy. * History of thyroid surgery, radioactive iodine therapy, or neck radiation therapy. * Current levothyroxine dose ≥0.1 mg at the time of enrollment.

Treatments Being Tested

DRUG

Levothyroxine tapering

Participants will undergo a gradual dose reduction of levothyroxine according to a standardized tapering protocol. The levothyroxine dose will be reduced every 3 months based on thyroid function test results. If thyroid function remains stable, the dose will be decreased by 0.025 mg (±0.0125 mg). If thyroid function remains stable at a low dose (≤0.025 mg), levothyroxine will be discontinued.

Locations (1)

Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam-si, South Korea