Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

Differentiated Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964284
• Other study ID #: ZGTSH003
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Yansong Lin, PhD
• Phone: +86-010-69156114
• Email: linys[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Biological:
• rhTSH
rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH

Radiation:
• Radioiodine (131I)
Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful postoperative thyroid ablation	Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan	8 months later by a rhTSH stimulated radioiodine scan