SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months — Up to 6 months after levothyroxine discontinuation
  The number and proportion of participants who are able to remain off levothyroxine for at least 6 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL).

Trial sites (1)

More Seoul National University Bundang Hospital trials in South Korea