Using rhTSH to improve radioiodine treatment for thyroid cancer
A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer
This study is testing if using a special hormone injection before radioiodine treatment helps people with thyroid cancer get better results than not using the hormone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04964284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of recombinant human thyroid-stimulating hormone (rhTSH) in patients with differentiated thyroid cancer who have undergone total or near-total thyroidectomy. Participants are randomized into two groups: one receiving rhTSH injections followed by oral radioiodine, and the other remaining hypothyroid before receiving radioiodine. The goal is to determine which method is more effective for thyroid remnant ablation. The study aims to provide insights into optimizing treatment protocols for thyroid cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed differentiated papillary or follicular thyroid carcinoma who have undergone thyroidectomy within the past year.
Not a fit: Patients with recent whole body scans, other malignancies, or serious comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of radioiodine therapy, leading to better outcomes for patients with differentiated thyroid cancer.
How similar studies have performed: Previous studies have shown promising results with rhTSH in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects voluntarily sign the informed consent form (ICF). * Age ≥ 18 years old, either male or female. * Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0. * Eastern Cooperative Oncology Group (ECOG) score of 0-2; * Expected life expectancy is greater than 12 weeks; * Patients with a total or near-total thyroidectomy within 12 months prior to randomized. * Low iodine diet for two weeks prior to randomized. Exclusion Criteria: * patients with recent history of 131I whole body scan within 2 weeks prior to randomized. * Pregnant or breast feeding women. * patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission) * Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator. * Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yansong Lin, PhD — Peking Union Medical College Hospital
- Study coordinator: Yansong Lin, PhD
- Email: linys@pumch.cn
- Phone: +86-010-69156114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.