Back to resultsEfficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer
Primary Purpose
Differentiated Thyroid Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhTSH
Radioiodine (131I)
Sponsored by
About this trial
This is an interventional treatment trial for Differentiated Thyroid Cancer
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rhTSH group
Thyroid hormone withdrawal group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The rate of successful postoperative thyroid ablation
Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan
Secondary Outcome Measures
Full Information
NCT ID
NCT04964284
First Posted
July 6, 2021
Last Updated
October 20, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04964284
Brief Title
Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhTSH group
Arm Type
Experimental
Arm Description
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.
Arm Title
Thyroid hormone withdrawal group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
rhTSH
Other Intervention Name(s)
Recombinant human thyroid-stimulating hormone
Intervention Description
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
Radiation
Intervention Name(s)
Radioiodine (131I)
Intervention Description
Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
Primary Outcome Measure Information:
Title
The rate of successful postoperative thyroid ablation
Description
Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan
Time Frame
8 months later by a rhTSH stimulated radioiodine scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yansong Lin, PhD
Phone
+86-010-69156114
Email
linys@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yansong Lin, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yansong Lin, PhD
Phone
+861069156114
Email
linys@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer
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