Recovery of hypothyroidism caused by immune checkpoint inhibitors after stopping treatment
SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
This trial will test whether adults who developed hypothyroidism while on immune checkpoint inhibitors can stop levothyroxine after those cancer drugs are stopped.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 107 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seongnam-si) |
| Trial ID | NCT07421869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥19 years) who developed hypothyroidism while receiving ICIs, started levothyroxine, have already stopped ICI therapy, and are currently taking less than 0.1 mg levothyroxine are ideal candidates.
Not a fit: Patients with prior thyroid surgery, radioactive iodine or neck radiation, those still on high-dose levothyroxine (≥0.1 mg), or those still receiving ICIs are unlikely to benefit.
Why it matters
Potential benefit: If successful, some patients may be able to stop long-term levothyroxine and avoid unnecessary lifelong thyroid replacement.
How similar studies have performed: Retrospective reports show that some patients recover thyroid function after stopping ICIs, but prospective, structured withdrawal data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.