NCT07752277已完成不适用
Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)
研究概览
简要总结
Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years, inclusive, regardless of sex.
- •Able to fully understand the study and voluntarily sign the informed consent form.
- •Histologically or cytologically confirmed advanced or metastatic thyroid cancer, treatment-naïve, and requiring total or near-total thyroidectomy.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •No clinically significant contraindications to surgery.
- •Body weight ≥50.0 kg for males and ≥45.0 kg for females, with a body mass index (BMI) of 19.0-26.0 kg/m², inclusive.
- •Able to maintain regular daily routines, communicate effectively with the investigator, comply with all study requirements, and adhere to scheduled study visits, treatment plans, and laboratory assessments.
- •Adequate baseline organ function at the screening visit, as demonstrated by local laboratory values meeting the protocol-specified eligibility requirements.
排除标准
- •Thyroid cancer patients for whom the planned or completed thyroidectomy does not meet the criteria for total or near-total thyroidectomy.
- •Prior treatment for thyroid cancer, including surgery and/or pharmacological treatment.
- •Major surgery, including radiosurgery, or significant traumatic injury within 2 weeks prior to randomization.
- •History of another malignancy within 3 years prior to initiation of study treatment.
- •Known history of a positive human immunodeficiency virus (HIV) test.
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; chronic or resolved HBV or HCV infection is permitted.
- •Congenital or acquired immunodeficiency.
- •History of clinically significant drug allergy or atopic allergic disease (e.g., asthma, urticaria, or eczematous dermatitis), or known hypersensitivity to Euthyrox (levothyroxine sodium) or any of its excipients.
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Patients on a stable-dose regimen of Euthyrox (levothyroxine sodium tablets) following total or near
结局指标
主要结局
TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)
时间窗: Preoperatively after enrollment, 19:00 on the day of surgery, and before medication on postoperative day 1 (patients accurately recorded the administration time to the minute; the medication time was set at 7:00), 7:30, 8:00, 8:30, and 9:00 on postoperat
Using mathematical and statistical methods (PopPK/PD) grounded in quantitative pharmacology to quantitatively describe, explain, and predict drug effects in vivo.
次要结局
未报告次要终点
研究者
研究点 (1)
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