Thyroid CancerPhase 1NCT07438847
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
A Phase 1 study testing 177Lu-CTR-FAPI therapy in people with Thyroid Cancer, run by SHAOYAN LIU at 2 sites in China.
Trial summary
This is a multi-center, open-label, single-arm, dose-escalation phase I study, aiming to evaluate the safety and efficacy of 177Lu-CTR-FAPI (covalent targeted radioligand-fibroblast activation protein inhibitor), a novel radiopharmaceutical in the treatment of thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- 177Lu-CTR-FAPI therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma must be diagnosed as radioactive iodine-refractory (RAIR) by a nuclear medicine specialist.
- Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging.
- Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease.
- Previous targeted therapy was discontinued due to intolerance, or lack of benefit from targeted therapy assessed by investigator, or patient refusal.
- At least one measurable target metastatic lesion on contrast-enhanced CT/MRI (longest diameter of lesion ≥ 10 mm or shortest diameter of lymph node ≥ 15 mm).
- Positive CTR-FAPI uptake in lesions, defined as SUVmax > 10 in more than half of the lesions on 68Ga-CTR-FAPI PET/CT.
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- Life expectancy > 6 months.
- ECOG performance status ≤ 2.
- Prior anti-tumor therapy-related toxicities that recoverd to Grade 0 or 1 (except alopecia, pigmentation, or chronic radiation toxicities and deemed irreversible by the investigator).
- For subjects with fertility: agreement to use effective contraception during treatment and 4 months (males) or 7 months (females) after the last dose.
- Voluntary participation and signed informed consent.
Who cannot join
- Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT).
- Prior therapeutic radionuclide therapy (except 131I).
- Systemic anti-cancer therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, or anti-tumor traditional Chinese medicine) within 4 weeks before the first dose.
- Participation in another drug or device clinical trial within 4 weeks before the first dose.
- Insufficient major organ function.
- Severe or uncontrolled comorbidities.
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- Presence of pleural effusion or ascites requiring intervention or judged uncontrolled by the investigator at screening.
- Active infection within 4 weeks before the first dose.
- Women who are pregnant, breastfeeding, or planning pregnancy.
- Known allergy to contrast agents.
- History of symptomatic central nervous system metastases.
- Other concurrent malignancies.
- Surgery under general anesthesia within 8 weeks before the first dose.
- History of acute coronary syndrome or stroke within 8 weeks before the first dose.
- Severe claustrophobia.
- Any other condition deemed inappropriate for participation by the investigator (e.g., poor compliance, inability to cooperate with treatment and follow-up).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Ziren Kong, M.D., 0086-18500487274, zrkong@126.com
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Xin Zhang, M.D., 0086-010-69154713, zhangxin37@pumch.cn
About this study
Official title: 177Lu-CTR-FAPI for the Treatment of Thyroid Cancer: A Prospective, Multi-center, Open-labeled, Single-arm, Phase I Study
This is a multi-center, open-label, single-arm, dose-escalation phase I study, aiming to evaluate the safety and efficacy of 177Lu-CTR-FAPI (covalent targeted radioligand-fibroblast activation protein inhibitor), a novel radiopharmaceutical in the treatment of thyroid cancer. The primary endpoint of the study is the safety of 177Lu-CTR-FAPI, and the secondary endpoints include treatment response and dosimetry evaluation.
Read the detailed description
This clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of 177Lu-CTR-FAPI in patients with thyroid cancer. The study is designed to characterize the safety profile and dose-limiting toxicities (DLTs) in order to determine the maximum tolerated dose (MTD) of 177Lu-CTR-FAPI. Additionally, the study will assess biochemical responses, radiological responses and improvement of life quality as well as the dosimetry profile of this molecule.
This is a multi-center, open-label, single-arm phase I trial using a classic "3+3" dose-escalation design. The starting dose is 100 mCi and increases in 50 mCi increments for subsequent cohort. The MTD is defined as the highest dose at which fewer than 33% of participants experience a DLT during the 6-week observation period following the first administration. A total of 12 eligible participants with thyroid cancer will be enrolled and receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks, for up to 4 cycles. Dose delays are permitted based on evaluation of treatment response or the necessity for recovery from adverse reactions, with a maximum delay of 12 weeks after the previous dose.
- Conditions
- Thyroid Cancer
- Being tested
- 177Lu-CTR-FAPI therapy
- Keywords
- Thyroid cancer, Radionuclide therapy, CTR-FAPI
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-CTR-FAPI therapyDrug
177Lu-CTR-FAPI will be diluted in 100 mL of normal saline and administered via slow intravenous infusion over 20-30 minutes. Dose will be escalated according to a "3+3" design, starting at 100 mCi and increasing in 50 mCi increments for subsequent cohort. Vital signs will be measured before and after drug administration. Throughout the infusion period, subjects will be closely monitored for any associated symptoms and adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-CTR-FAPI Arm | Experimental | Participants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design will be utilized, with starting dose of 100mCi and subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on the recovery from adverse reactions and treatment response. Receives: Drug: 177Lu-CTR-FAPI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events, frequency of dose-limiting toxicities and maximum tolerated dose of 177Lu-CTR-FAPI in patients with thyroid cancer.
Incidence and severity of adverse events, frequency of dose-limiting toxicities(DLTs) will be evaluated within the 6-week observation period following the first administration of 177Lu-CTR-FAPI. DLTs will be assesse based on Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
The Maximum Tolerated Dose (MTD) will be defined as the highest dose at which fewer than 33% of participants experience a DLT during the 6-week observation period following the first administration.
Measured: From enrollment to 6 weeks after the first injection of 177Lu-CTR-FAPI.
Secondary outcomes (10)
Biochemical response rate
Biochemical response of participants is deifined by the change of serum tumor markers (thyroglobulin for differentiated thyroid carcinoma and calcitonin for medullary thyroid carcinoma) from baseline as follows:
Progressive disease (PD) is defined as more than 50% increase of serum tumor markers; Stable disease (SD) is defined as less than 50% increase or 50% reduction of serum tumor markers; Partial response (PR) is defined as more than 50% reduction of baseline serum tumor markers; Complete response (CR) is defined as normalization of serum tumor markers.
The overall response rate (ORR) is measured as the proportion of participants achieving biochemical CR or PR, and the disease control rate (DCR) is defined as the proportion of participants achieving biochemical CR, PR, or SD.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Duration of biochemical response
Duration of biochemical response is measured as the time period during which participants achieving biochemical CR or PR.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Radiological response rate
The radiological response is evaluated by radiological examinations, including contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
The ORR is measured as the proportion of participants achieving CR or PR, and the DCR is defined as the proportion of participants achieving CR, PR, or SD.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Duration of radiological response
Duration of radiological response is measured as the time period during which participants achieving radiological CR or PR.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Progression-free survival
Progression-free survival (PFS) is defined as the time from enrollment until the first occurrence of disease progression or death from any cause, whichever occurs earlier.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Overall survival
Overall survival (OS) is defined as the time from enrollment until death from any cause.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Change of quality of life score
Change of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) scores compared with baseline is measured to evaluate improvement of life quality, in which a higher score of Function Scales and Global Health Status / Quality of Life Scale (transformed range 0-100) indicates better functioning or a higher quality of life and a lower score of Symptom Scales (transformed range 0-100) indicates less severity or frequency of the symptom.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Change of Pain score
Change of Brief Pain Inventory (BPI) scores compared with baseline is measured to evaluate pain severity (range 0-10) and pain interference (range 0-10), and a lower score indicates a better outcome.
Measured: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
The absorbed doses for major organs and tumors of 177Lu-CTR-FAPI
After the first administration, participants will undergo radiation dosimetry assessments.
Blood samples will be collected at specific time points for radioactivity measurements.
Whole-body planar imaging as well as regional quantitative single photon emission computed tomography/computed tomography (SPECT/CT) at specific time points will also be performed. Regions of interest (ROI) will be delineated on SPECT images for lesions, kidneys, bone marrow, total skeleton, heart, liver, and spleen. These ROIs will be projected onto the whole-body images to derive time-activity curves and residence times. The OLINDA software will then be used to calculate the absorbed radiation doses in tumors and normal organs.
Measured: From enrollment to 8 days after the first administration
The maximum dose
The maximum dose will be acquired based on the organ dose limits calculated from the radiation dosimetry assessments.
Measured: From enrollment to 8 days after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A total of 12 adult participants with thyroid cancer will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design is employed. The starting dose is 100 mCi, with subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on recovery from adverse reactions and reatment response. Participants will undergo structured monitoring and follow-up visit to assess safety, efficacy, and long-term outcomes.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SHAOYAN LIU
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Tsinghua Changgeng Hospital, Navy General Hospital, Beijing
- Responsible party
- Sponsor-investigator, SHAOYAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yansong Lin, M.D., Principal investigator, Peking Union Medical College HospitalShaoyan Liu, M.D., Principal investigator, Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438847
- Sponsor's protocol ID
- BRP-010-003
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.
PubMed 39470165Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.
PubMed 38778111
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-CTR-FAPI for the Treatment of Thyroid Cancer: A Prospective, Multi-center, Open-labeled, Single-arm, Phase I Study
- ClinicalTrials.gov ID
- NCT07438847
- Acronym / sponsor ID
- BRP-010-003
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid cancer, Radionuclide therapy, CTR-FAPI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SHAOYAN LIUUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Tsinghua Changgeng Hospital, Navy General Hospital, Beijing
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 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.
This is a multi-center, open-label, single-arm, dose-escalation phase I study, aiming to evaluate the safety and efficacy of 177Lu-CTR-FAPI (covalent targeted radioligand-fibroblast activation protein inhibitor), a novel radiopharmaceutical in the treatment of thyroid cancer. The primary endpoint of the study is the safety of 177Lu-CTR-FAPI, and the secondary endpoints include treatment response and dosimetry evaluation.
Detailed description
This clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of 177Lu-CTR-FAPI in patients with thyroid cancer. The study is designed to characterize the safety profile and dose-limiting toxicities (DLTs) in order to determine the maximum tolerated dose (MTD) of 177Lu-CTR-FAPI. Additionally, the study will assess biochemical responses, radiological responses and improvement of life quality as well as the dosimetry profile of this molecule.
This is a multi-center, open-label, single-arm phase I trial using a classic "3+3" dose-escalation design. The starting dose is 100 mCi and increases in 50 mCi increments for subsequent cohort. The MTD is defined as the highest dose at which fewer than 33% of participants experience a DLT during the 6-week observation period following the first administration. A total of 12 eligible participants with thyroid cancer will be enrolled and receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks, for up to 4 cycles. Dose delays are permitted based on evaluation of treatment response or the necessity for recovery from adverse reactions, with a maximum delay of 12 weeks after the previous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of 12 adult participants with thyroid cancer will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design is employed. The starting dose is 100 mCi, with subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on recovery from adverse reactions and reatment response. Participants will undergo structured monitoring and follow-up visit to assess safety, efficacy, and long-term outcomes.
| Arm | Type | Receives |
|---|---|---|
| 177Lu-CTR-FAPI Arm | Experimental | Drug: 177Lu-CTR-FAPI therapyParticipants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. A standard "3+3" dose-escalation design will be utilized, with starting dose of 100mCi and subsequent dose levels increasing by 50 mCi increments. Dose delays are permitted based on the recovery from adverse reactions and treatment response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of thyroid cancer according to the 2022 WHO classification of thyroid tumors. Differentiated thyroid carcinoma must be diagnosed as radioactive iodine-refractory (RAIR) by a nuclear medicine specialist.
- Evidence of progressive disease based on RECIST 1.1 criteria in pre-treatment imaging.
- Prior surgical resection of resectable cervical lesions, with currently unresectable systemic disease.
- Previous targeted therapy was discontinued due to intolerance, or lack of benefit from targeted therapy assessed by investigator, or patient refusal.
- At least one measurable target metastatic lesion on contrast-enhanced CT/MRI (longest diameter of lesion ≥ 10 mm or shortest diameter of lymph node ≥ 15 mm).
Key exclusion criteria (16 listed)
- Presence of CTR-FAPI-negative lesions (i.e., malignant lesions on contrast-enhanced CT/MRI without uptake on 68Ga-CTR-FAPI PET/CT).
- Prior therapeutic radionuclide therapy (except 131I).
- Systemic anti-cancer therapy (including chemotherapy, targeted therapy, immunotherapy, radionuclide therapy, or anti-tumor traditional Chinese medicine) within 4 weeks before the first dose.
- Participation in another drug or device clinical trial within 4 weeks before the first dose.
- Insufficient major organ function.
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 |
|---|---|---|
| 177Lu-CTR-FAPI therapy177Lu-CTR-FAPI will be diluted in 100 mL of normal saline and administered via slow intravenous infusion over 20-30 minutes. Dose will be escalated according to a "3+3" design, starting at 100 mCi and increasing in 50 mCi increments for subsequent cohort. Vital signs will be measured before and after drug administration. Throughout the infusion period, subjects will be closely monitored for any associated symptoms and adverse reactions. | Drug | 177Lu-CTR-FAPI Arm |
Primary outcome
Incidence and severity of adverse events, frequency of dose-limiting toxicities and maximum tolerated dose of 177Lu-CTR-FAPI in patients with thyroid cancer.
Time frame: From enrollment to 6 weeks after the first injection of 177Lu-CTR-FAPI.
Incidence and severity of adverse events, frequency of dose-limiting toxicities(DLTs) will be evaluated within the 6-week observation period following the first administration of 177Lu-CTR-FAPI. DLTs will be assesse based on Common Terminology Criteria for Adverse Events (CTCAE) 5.0. The Maximum Tolerated Dose (MTD) will be defined as the highest dose at which fewer than 33% of participants experience a DLT during the 6-week observation period following the first administration.
10 secondary outcomes
Biochemical response rate
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Duration of biochemical response
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Radiological response rate
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Duration of radiological response
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Progression-free survival
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Overall survival
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Change of quality of life score
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
Change of Pain score
Time frame: From enrollment to 1 year after the last 177Lu-CTR-FAPI injection.
The absorbed doses for major organs and tumors of 177Lu-CTR-FAPI
Time frame: From enrollment to 8 days after the first administration
The maximum dose
Time frame: From enrollment to 8 days after the first administration
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 27 Feb 2026.
- Background: PubMed 39470165Kong Z, Li Z, Cui XY, Wang J, Xu M, Liu Y, Chen J, Ni S, Zhang Z, Fan X, Huang J, Lin Y, Sun Y, He Y, Lin X, Meng T, Li H, Song Y, Peng B, An C, Gao C, Li N, Liu C, Zhu Y, Yang Z, Liu Z, Liu S. CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma. Cancer Discov. 2025 Feb 7;15(2):316-328. doi: 10.1158/2159-8290.CD-24-0897.
- Background: PubMed 38778111Cui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22.
- 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.
Yansong Lin, M.D. principal investigator
Peking Union Medical College Hospital
Shaoyan Liu, M.D. principal investigator
Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-CTR-FAPI therapy in people with Thyroid Cancer, run by SHAOYAN LIU at 2 sites 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 11 inclusion and 16 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ziren Kong, M.D. (0086-18500487274, zrkong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events, frequency of dose-limiting toxicities and maximum tolerated dose of 177Lu-CTR-FAPI in patients with thyroid cancer. (time frame: From enrollment to 6 weeks after the first injection of 177Lu-CTR-FAPI.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438847, which also lists 2 linked publications.
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 27 Feb 2026.