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

NCT04964284 | Unknown Phase 3

• 1 other identifier: ZGTSH003
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

rhTSH group

EXPERIMENTAL

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; Radiation: Radioiodine (131I)

Thyroid hormone withdrawal group

EXPERIMENTAL

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)

Interventions

rhTSH BIOLOGICAL

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

Also known as: Recombinant human thyroid-stimulating hormone

rhTSH group

Radioiodine (131I) RADIATION

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

Thyroid hormone withdrawal group; rhTSH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Thyrotropin Alfa; Iodine-131

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yansong Lin, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yansong Lin, PhD

CONTACT

+86-010-69156114; linys@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: October 6, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (1)