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A shot to skip the misery of thyroid hormone withdrawal before cancer treatment?

NCT ID NCT04964284

Disease control Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving recombinant human thyrotropin (rhTSH) injections before radioactive iodine can effectively destroy leftover thyroid tissue after surgery for differentiated thyroid cancer. Normally, patients must stop thyroid hormone medication to raise TSH levels, which causes uncomfortable hypothyroidism. The study compares this standard approach with rhTSH injections that raise TSH without stopping medication. About 390 adults who had their thyroid removed will be randomly assigned to one of the two methods, and success is measured by the absence of visible thyroid tissue on a scan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant human thyrotropin (rhTSH) injections followed by radioactive iodine (131I)
What this could lead to
If successful, this approach could allow patients to avoid the discomfort and risks of stopping thyroid hormone therapy before radioactive iodine treatment, while achieving similar ablation success.
What could go wrong
The trial is still in progress, and results are not yet known. rhTSH may not be as effective as the standard hypothyroid method, and radioactive iodine carries risks such as dry mouth or low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

390 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

differentiated thyroid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Differentiated thyroid cancer

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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Other studies related to the condition(s) this trial covers.