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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2024

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: rhTSH group
    • Patients received thyroid hormone suppression therapy (Euthyrox) . rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
  • Experimental: Thyroid hormone withdrawal group
    • After randomization, patients with thyroid hormone withdrawal therapy(i.e. Stop taking thyroid hormone for 14 days, and then monitor the level of thyroid-stimulating hormone every week). When TSH>30mU/L, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of successful postoperative thyroid ablation
    • Time Frame: 8 months later by a rhTSH stimulated radioiodine scan
    • Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yansong Lin, PhD, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Yansong Lin, PhD, +86-010-69156114, linys@pumch.cn

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.