Clinical trial · Observational
Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients
NCT07752277CI-TRIAL-00121920completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients on a stable-dose regimen of Euthyrox (levothyroxine sodium tablets) following total or near
Primary outcomes (1)
- measure
- TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb)
- timeFrame
- 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
- description
- Using mathematical and statistical methods (PopPK/PD) grounded in quantitative pharmacology to quantitatively describe, explain, and predict drug effects in vivo.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 ≤2. * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.