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Efficacy of Recombinant Human Thyrotropin-Assisted Radioiodine (Iodine-131) Oncolytic Therapy for Metastatic Differentiated Thyroid Cancer Versus Thyroid Hormone Withdrawal

Efficacy of Recombinant Human Thyrotropin-Assisted Radioiodine (Iodine-131) Oncolytic Therapy for Metastatic Differentiated Thyroid Cancer Versus Thyroid Hormone Withdrawal: A Randomized Controlled Non-inferiority Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112654
Enrollment
Unknown
Registered
2025-11-18
Start date
2025-11-28
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic differentiated thyroid cancer

Interventions

Discontinue medication:Levothyroxine withdrawl for 4 weeks? TSH > 30 mIU/L
Day 3: Oral administration of iodine-131 (200 mCi)
LT4 was restored 24 hours after taking the iodine.
Recombinant Human Thyrotropin Injection:Take LT4 throughout the treatment
Day 1-2: Intramuscular injection of rhTSH 0.9mg in the buttocks
Day 3: Oral administration of iodine-131 (200mCi) for oncolytic therapy.

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 75 years old; 2. Patients with differentiated thyroid cancer confirmed by pathology and scheduled for RAI treatment for the first time; 3. Underwent total or near-total thyroidectomy; 4. With distant measurable metastatic lesions indicated by biopsy or imaging examinations (including ultrasound, iodine-131 whole-body scan, CT, MRI or PET/CT); 5. Capable of making decisions and voluntarily participating in this clinical study, and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are breastfeeding or pregnant; 2. Those with malignant tumors other than differentiated thyroid cancer; 3. Patients not in a TSH suppression state; 4. Patients unable to comply with radiation protection requirements; 5. Those with an expected survival period of less than 6 months; 6. Those allergic to rhTSH or its excipients; 7. Those who have used iodine contrast agents within one month before the surgery or have not followed a low-iodine diet within two weeks before the surgery; 8. Other patients considered unsuitable for participating in this clinical study by the researchers.

Design outcomes

Primary

MeasureTime frame
Objective Remission Rate;CT indicators;The shrinking effect of a single iodine-31 treatment;

Secondary

MeasureTime frame
Thyroid function;Thyroglobulin;Renal function;Lipid profile;Thyroglobulin antibodies;Lodine-131 whole body scan + SPECT/CT indicators;

Countries

China

Contacts

Public ContactLibo Chen

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

lbchen@sjtu.edu.cn+86 138 1691 4365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026