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

Study Overview

• Status: Recruiting
• Conditions: Differentiated Thyroid Cancer
• Intervention / Treatment: Biological: rhTSH; Radiation: Radioiodine (131I)

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yansong Lin, PhD; Phone Number: +86-010-69156114; Email: linys@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yansong Lin, PhD; Phone Number: +861069156114; Email: linys@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Other Names: Recombinant human thyroid-stimulating hormone; Radiation: Radioiodine (131I); Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
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.	Radiation: Radioiodine (131I); Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Yansong Lin, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: ZGTSH003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No