Recovery of hypothyroidism caused by immune checkpoint inhibitors after stopping treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults who developed hypothyroidism during immune checkpoint inhibitor (ICI) therapy, have discontinued ICIs, and are taking levothyroxine. Participants will undergo a stepwise levothyroxine taper every three months if thyroid function tests remain normal, with planned discontinuation if they maintain normal tests on a low dose (≤0.025 mg). Thyroid function tests and clinical symptoms will be monitored at each visit to detect recovery or relapse. The study will quantify the proportion of patients who can stop thyroid replacement and analyze clinical and laboratory factors that predict successful withdrawal.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Min Joo Kim, Professor
• Email: mjkim@snubh.org
• Phone: +82-31-787-7855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.