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

NCT ID: NCT04964284

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

rhTSH

Intervention Type: BIOLOGICAL

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

Radioiodine (131I)

Intervention Type: RADIATION

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

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.

Group Type: EXPERIMENTAL

Radioiodine (131I)

Intervention Type: RADIATION

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

Interventions

rhTSH

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

Intervention Type: BIOLOGICAL

Radioiodine (131I)

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

Intervention Type: RADIATION

Other Intervention Names

Recombinant human thyroid-stimulating hormone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yansong Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yansong Lin, PhD

Role: CONTACT

linys@pumch.cn

+86-010-69156114

Facility Contacts

Yansong Lin, PhD

Role: primary

linys@pumch.cn

+861069156114

Other Identifiers

ZGTSH003

Identifier Type: -

Identifier Source: org_study_id