SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Levothyroxine tapering (Drug)
结局指标
主要结局
Proportion of participants who maintain discontinuation of levothyroxine for at least 6 months
时间窗: 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).
次要结局
- Proportion of participants who can discontinue levothyroxine(up to 3 years after study enrollment)
- Proportion of participants who maintain discontinuation of levothyroxine for at least 12 months(Up to 12 months after levothyroxine discontinuation)
- Proportion of participants who maintain discontinuation of levothyroxine for at least 36 months(Up to 36 months after levothyroxine discontinuation)
研究者
Min Joo Kim
Professor
Seoul National University Bundang Hospital