SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial (S-CORT)

February 11, 2026 updated by: Min Joo Kim, Seoul National University Bundang Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • South Korea
      • Seongnam-si, South Korea
        • Recruiting
        • Department of Internal Medicine, Seoul National University Bundang Hospital
        • Contact:
          • Department of Internal Medicine, Seoul National University Bun
          • Phone Number: +82-787-7029
          • Email: hjk@snubh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine tapering arm
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 6 months after levothyroxine discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 years after study enrollment
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).
Up to 12 months after levothyroxine discontinuation
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).
Up to 36 months after levothyroxine discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Estimated)

March 4, 2029

Study Completion (Estimated)

March 4, 2029

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-B-2401-879-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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