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Completed

NCT Number: NCT07752277

Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Aged 18-65 years (inclusive), any gender; 2.Able to fully understand and voluntarily sign the informed consent form; 3.Patients with histologically or cytologically confirmed advanced/metastatic thyroid cancer who are treatment-naïve and require total or near-total thyroidectomy; 4.ECOG performance status ≤ 2; 5.No obvious contraindications to surgery; 6.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 of 19.0 and 26.0); 7.Subjects with regular daily routines, capable of maintaining good communication with the investigator and complying with all clinical trial requirements, and willing and able to adhere to the scheduled protocol visits, treatment plan, and laboratory assessments; 8.Patients must have adequate baseline organ function at the screening visit, including local laboratory values meeting the inclusion criteria as specified below.

Exclusion criteria

  • 1.Thyroid cancer patients whose thyroidectomy does not meet the criteria for total or near-total resection; 2.Patients with prior treatment for thyroid cancer (including surgery and/or medication); 3.Patients who have undergone major surgery (including radiosurgery) or experienced significant traumatic injury within 2 weeks prior to randomization; 4.History of other malignancies within <3 years prior to the initiation of study treatment; 5.Subjects with a known history of positive human immunodeficiency virus (HIV) testing; 6.Known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) (chronic or resolved HBV and HCV infections are permitted); 7.Patients with congenital or acquired immunodeficiency; 8.History of clinically significant drug allergy or atopic allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known hypersensitivity to Euthyrox (levothyroxine sodium) or any of its excipients; 9.Pregnant or lactating females.

Treatment and study plan

Primary outcomes

  1. TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 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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