DTC - Differentiated Thyroid CancerNCT06405217
Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment
A study testing Recombinant Human Thyroid Stimulating Hormone in people with DTC - Differentiated Thyroid Cancer and Thyroid Stimulating; Hormone, C, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer . Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- DTC - Differentiated Thyroid Cancer, Thyroid Stimulating; Hormone, C, Radiotherapy; Complications
- What is being tested?
- Recombinant Human Thyroid Stimulating Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age: 18~75 years old (including 18 and 75 years old);
- ECOG: 0-2 points;
- Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
- Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
- Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
- Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up.
Who cannot join
- Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar \>10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
- Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
- Unable to quit or with a history of psychiatric medication abuse;
- Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;
- Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;
- Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;
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- Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;
- Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;
- Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Feng Wang, Ph.D., 86-025-52271455, fengwangcn@hotmail.com
About this study
Official title: Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .
Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.
The two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (>30mU/L). The efficacy and adverse reactions were observed.
- Conditions
- DTC - Differentiated Thyroid Cancer, Thyroid Stimulating; Hormone, C, Radiotherapy; Complications
- Being tested
- Recombinant Human Thyroid Stimulating Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Thyroid Stimulating HormoneDrug
Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human thyroid stimulating hormone group | Experimental | Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days Receives: Drug: Recombinant Human Thyroid Stimulating Hormone |
| Withdraw group | No intervention | Thyroid hormone withdraw for 4-6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of hyroid stimulating hormone elevation
The proportion of patients with thyroid stimulating hormone>30 mIU/L
Measured: For patients in the experimental group: 24 hours after the second time of recombinant human thyroid stimulating hormone injection; For patients in the no intervention group: 4 to 6 weeks after thyroid hormone withdraw
Incidence of Treatment-Emergent Adverse Events
This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
Measured: Time interval from start to 3 months after completion of the therapy
Secondary outcomes (1)
Overall response rate
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria (RECIST v1.1 criteria) in Solid Tumors
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start20 Apr 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DTC - Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405217
- Sponsor's protocol ID
- KY20240419-09
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06405217
- Acronym / sponsor ID
- KY20240419-09
- Conditions
- DTC - Differentiated Thyroid Cancer, Thyroid Stimulating; Hormone, C, Radiotherapy; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 May 2024 (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.
Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .
Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.
The two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (>30mU/L). The efficacy and adverse reactions were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant human thyroid stimulating hormone group | Experimental | Drug: Recombinant Human Thyroid Stimulating HormoneRecombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days |
| Withdraw group | No intervention | –Thyroid hormone withdraw for 4-6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18~75 years old (including 18 and 75 years old);
- ECOG: 0-2 points;
- Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
- Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
- Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
Key exclusion criteria (9 listed)
- Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar \>10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
- Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
- Unable to quit or with a history of psychiatric medication abuse;
- Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;
- Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;
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 HormoneRecombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days | Drug | Recombinant human thyroid stimulating hormone group |
Primary outcome
The rate of hyroid stimulating hormone elevation
Time frame: For patients in the experimental group: 24 hours after the second time of recombinant human thyroid stimulating hormone injection; For patients in the no intervention group: 4 to 6 weeks after thyroid hormone withdraw
The proportion of patients with thyroid stimulating hormone>30 mIU/L
Incidence of Treatment-Emergent Adverse Events
Time frame: Time interval from start to 3 months after completion of the therapy
This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
1 secondary outcome
Overall response rate
Time frame: 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Human Thyroid Stimulating Hormone in people with DTC - Differentiated Thyroid Cancer and Thyroid Stimulating; Hormone, C, run by Nanjing First Hospital, Nanjing Medical University 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 May 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of hyroid stimulating hormone elevation (time frame: For patients in the experimental group: 24 hours after the second time of recombinant human thyroid stimulating hormone injection; For patients in the no intervention group: 4 to 6 weeks after thyroid hormone withdraw). The study lists 2 primary outcomes in all. 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 8 May 2024.