Differentiated Thyroid CancerPhase 2NCT04447183
rhTSH for Radioactive Iodine Remnant Ablation in Differentiated Thyroid Cancer
A Phase 2 study testing Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH) and radioactive iodine in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH) and radioactive iodine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2020to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)
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.
Read the 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.
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH), radioactive iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)Drug
Also called radioactive iodine
rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
radioactive iodineOther
radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | 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. Receives: Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH); Other: radioactive iodine |
| Control group | Experimental | 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. Receives: Other: radioactive iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 36
Secondary outcomes (2)
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.
Measured: at week 36
Adverse Event
Classification and degree of adverse events
Measured: up to week 40 ± 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start23 Nov 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, open, parallel controlled, multi-center clinical trial
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yansong Lin, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447183
- Sponsor's protocol ID
- ZGTSH002
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)
- ClinicalTrials.gov ID
- NCT04447183
- Acronym / sponsor ID
- ZGTSH002
- Conditions
- Differentiated Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open, parallel controlled, multi-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH), Other: radioactive iodineThe 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. |
| Control group | Experimental | Other: radioactive iodineThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)Also: radioactive iodinerhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral | Drug | Test group |
| radioactive iodineradioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral | Other | Control group, Test group |
Primary outcome
Ablation success rate by Diagnostic Whole Body Scan (DxWBS)
Time frame: at week 36
In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.
2 secondary outcomes
Serum thyroglobulin (Tg) levels
Time frame: at week 36
Adverse Event
Time frame: up to week 40 ± 7 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yansong Lin, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH) and radioactive iodine in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablation success rate by Diagnostic Whole Body Scan (DxWBS) (time frame: at week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.