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NCT Number: NCT07421869

SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery 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

Recruiting

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location status: Recruiting

Location contact

Department of Internal Medicine, Seoul National University Bun

CONTACT

[email protected]

+82-787-7029

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine tapering

Drug

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.

Primary outcomes

  1. Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months

    Time frame: 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).

Secondary outcomes

  1. Proportion of participants who can discontinue levothyroxine

    Time frame: up to 3 years after study enrollment

    The number and proportion of participants who were able to discontinue levothyroxine after dose reduction during the study follow-up period, regardless of whether the discontinuation was sustained. This includes any participant who temporarily stopped levothyroxine for any duration, even if the medication was later resumed.

  2. Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months

    Time frame: Up to 12 months after levothyroxine discontinuation

    The number and proportion of participants who are able to remain off levothyroxine for at least 12 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL).

  3. Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months

    Time frame: Up to 36 months after levothyroxine discontinuation

    The number and proportion of participants who are able to remain off levothyroxine for at least 36 consecutive months without requiring re-initiation of treatment due to abnormal thyroid function (serum TSH level ≥10 μIU/mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Min Joo Kim, Professor

CONTACT

[email protected]

+82-31-787-7855

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Acronym: S-CORT

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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