The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer. (DTC)

A Phase II Study of the Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.

Study Overview

• Status: Active, not recruiting
• Conditions: Differentiated Thyroid Cancer
• Intervention / Treatment: Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH); Other: radioactive iodine

Detailed Description

This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). 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 Thyrogen (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. All patients received the same amount of radioactive iodine (30mCi±1.5mCi or 1.11GBq of 131I). Approximately 9 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

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
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
• Patients who were at 18~75 years old (male or female).
• Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation.
• Serum TSH ≤ 0.5 mU/L；
• Women of childbearing age are HCG-negative;
• Low iodine diet before enrollment for more than 4 weeks;
• Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.

Exclusion Criteria:

• Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
• Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration;
• Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);
• Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;
• Pregnant or lactating women;
• Patients who are allergic to rhTSH and its excipients;
• Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS;
• Participated in any drug or medical device clinical trial within 1 month prior to the trial.

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: Test group; The test 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 Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine.	Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH); rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral; Other Names: radioactive iodine; Other: radioactive iodine; radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
Experimental: Control group; The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.	Other: radioactive iodine; radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation success rate by Diagnostic Whole Body Scan (DxWBS)	In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.	at week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum thyroglobulin (Tg) levels	In the THW state (TSH≥30mU/L), the proportion of patients with Tg levels <1ng/mL and neck B-ultrasound negative during rhTSH stimulation accounted for all subjects.	at week 36
Adverse Event	Classification and degree of adverse events	up to week 40 ± 7 day

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): November 23, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

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; Anti-Infective Agents, Local; Anti-Infective Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Trace Elements; Micronutrients; Iodine; Hormones
• Other Study ID Numbers: ZGTSH002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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