Thyroid Cancer Stage IVNCT07755423
Stereotactic Body Radiotherapy for the Treatment of Distant Metastases in Thyroid Cancer: A Phase II Prospective Clinical Study
An observational study of Thyroid Cancer Stage IV, run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the efficacy and safety of Stereotactic Body Radiotherapy in the treatment of distant metastatic thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer Stage IV
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Distant metastasis of thyroid cancer
Who may be able to join
- Participants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5).
- Participants who have failed prior systemic therapy. Systemic therapy includes radioactive iodine therapy, immunotherapy, targeted therapy, clinical trial therapy, etc.
- Age: 18 - 70 years old.
- KPS ≥ 70.
- Expected survival period ≥ 3 months.
- Before treatment, neutrophils ≥ 1.6 × 109/L, hemoglobin ≥ 80g/L, platelets ≥ 80×109/L; creatinine clearance rate ≥ 60 ml/min; non-hepatic metastasis patients (total bilirubin ≤ 1.5 times the upper limit of normal, ALT ≤ 1.5 times the upper limit of normal, AST ≤ 1.5 times the upper limit of normal), hepatic metastasis patients (total bilirubin ≤ 3 times the upper limit of normal, ALT ≤ 3 times the upper limit of normal, AST ≤ 3 times the upper limit of normal, normal coagulation function, Child-Pugh grade A or B, normal liver tissue volume > 700 mL)
- Signed informed consent form and willing to complete the study according to the protocol.
Who cannot join
- Patients who achieved complete remission after comprehensive treatment.
- Pathologically confirmed as a second primary tumor.
- Received radiotherapy to the corresponding area and the radiotherapy site overlapped with this one.
- Uncontrollable malignant pleural or peritoneal effusion.
- Severe internal medical complications and contraindications to radiotherapy.
- Pregnant women of childbearing age with positive pregnancy test or lactating women.
- Active mental disorders or other psychological disorders that affected the patient's signing of informed consent and understanding ability.
- Uncontrollable infections or active infections, such as immunodeficiency or AIDS patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to evaluate the efficacy and safety of Stereotactic Body Radiotherapy in the treatment of distant metastatic thyroid cancer.
- Conditions
- Thyroid Cancer Stage IV
- Being tested
- SBRT
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Participants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | radiotherapy Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate，DCR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755423
- Sponsor's protocol ID
- TC-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy for the Treatment of Distant Metastases in Thyroid Cancer: A Phase II Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07755423
- Acronym / sponsor ID
- TC-01
- Conditions
- Thyroid Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Aug 2026 (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.
The goal of this observational study is to evaluate the efficacy and safety of Stereotactic Body Radiotherapy in the treatment of distant metastatic thyroid cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Radiation: SBRTradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Distant metastasis of thyroid cancer
Key inclusion criteria (7 listed)
- Participants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5).
- Participants who have failed prior systemic therapy. Systemic therapy includes radioactive iodine therapy, immunotherapy, targeted therapy, clinical trial therapy, etc.
- Age: 18 - 70 years old.
- KPS ≥ 70.
- Expected survival period ≥ 3 months.
Key exclusion criteria (8 listed)
- Patients who achieved complete remission after comprehensive treatment.
- Pathologically confirmed as a second primary tumor.
- Received radiotherapy to the corresponding area and the radiotherapy site overlapped with this one.
- Uncontrollable malignant pleural or peritoneal effusion.
- Severe internal medical complications and contraindications to radiotherapy.
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 |
|---|---|---|
| SBRTParticipants with primary lesion pathologically confirmed as thyroid cancer, and distant metastatic lesions confirmed either by pathology or by two types of imaging modalities. Based on the investigator's judgment, the participant's distant metastatic lesions are expected to be tolerable to Stereotactic Body Radiotherapy (SBRT). The distant metastases should be oligometastatic (total number of metastatic lesions ≤ 5). | Radiation | treatment group |
Primary outcome
Disease Control Rate，DCR
Time frame: 3 months
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 10 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer Stage IV, run by Fudan 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 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: enrolling by invitation, as of the sponsor's last update on 10 Aug 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.
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?
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?
Disease Control Rate，DCR (time frame: 3 months). 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 10 Aug 2026.