NCT07421869

SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2029-03-04
• Completion: 2029-03-04
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: South Korea