Thyroid Eye Disease, TEDPhase 2TOFA-GONCT07547930
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
A Phase 2 study testing Tofacitinib in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease, TED, Graves Ophthalmopathy, Graves Orbitopathy
- What is being tested?
- Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 30 Dec 2027
- Phase
- Phase 2
- 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 and Gender: Male or female participants aged 18 to 75 years (inclusive).
- Diagnosis: Clinical diagnosis of Graves' orbitopathy (GO) consistent with EUGOGO criteria.
- Severity: Moderate-to-severe GO as defined by EUGOGO guidelines (impact on daily life, but not sight-threatening).
- Activity: Active disease, defined as a Clinical Activity Score (CAS) >=3 points (on the 7-point scale).
- Refractory Status (Must meet ONE of the following):Glucocorticoid-Resistant: Failure to respond (no significant improvement in proptosis or CAS) after receiving a cumulative dose of at least 3g of intravenous methylprednisolone (or equivalent).Glucocorticoid-Intolerant: Documented contraindications to high-dose systemic glucocorticoids (e.g., uncontrolled diabetes mellitus, severe osteoporosis, glaucoma, severe psychiatric disorders) or history of severe adverse events leading to discontinuation.
- Thyroid Function: Euthyroid or mild hypothyroidism/hyperthyroidism maintained on stable antithyroid drugs or thyroxine replacement therapy for at least 4 weeks prior to baseline.
- Contraception: Women of childbearing potential must agree to use effective contraception during the study period and for at least 4 weeks after the last dose of the study drug.
- Consent: Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- 1.Sight-Threatening Disease: Presence of Dysthyroid Optic Neuropathy (DON) or severe corneal breakdown requiring immediate surgical intervention.
- 2.Chronic/Inactive Disease: Fibrotic or burnout stage of GO with a Clinical Activity Score (CAS) < 3.
- 3.Prior Orbital Treatment:Orbital radiotherapy at any time.Orbital surgical decompression at any time.Strabismus surgery or eyelid surgery within 3 months prior to baseline.
- 4.Concomitant Immunomodulation: Use of other biologic agents (e.g., Teprotumumab, Rituximab, Tocilizumab) within 3 months prior to baseline.
- 5.Active Infection Risk (Critical for JAK Inhibitors):Active tuberculosis (TB) or untreated latent TB.Active or chronic Hepatitis B or Hepatitis C infection.Human Immunodeficiency Virus (HIV) infection.History of disseminated herpes zoster or herpes simplex.Any severe active infection requiring hospitalization or IV antibiotics within 4 weeks of baseline.
- 6.Thrombosis Risk: History of venous thromboembolism (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE), or known coagulation disorders.
- 8.Malignancy: History of any malignancy within the past 5 years (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).
- 9.Laboratory Abnormalities:Absolute Neutrophil Count (ANC) < 1.0 10^9/L and/or Absolute Lymphocyte Count (ALC) < 0.5 10^9/L and /or Hemoglobin < 90 g/L and/or AST or ALT > 2 Upper Limit of Normal (ULN) and/or Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m²
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
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Fangsen Xiao, MD, 13859955389, xfs888@163.com
Liying Wang, MM, +86-592-2137710, wlywly1979@163.com
About this study
Official title: A Single-Arm, Open-Label, Exploratory Study of Tofacitinib in Patients With Glucocorticoid-Resistant or Intolerant Moderate-to-Severe Active Thyroid Eye Disease
Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects.
This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.
Read the detailed description
Thyroid Eye Disease (TED) involves complex pathogenesis where orbital fibroblasts are activated by autoantibodies targeting the TSH receptor (TSHR) and the Insulin-like Growth Factor-1 receptor (IGF-1R). Current evidence suggests that TSHR and IGF-1R form a physical and functional complex that activates downstream signaling cascades, prominently the Janus Kinase/Signal Transducer and Activator of Transcription (JAK-STAT) pathway. The activation of STAT3, in particular, is a critical driver of hyaluronan synthesis, adipogenesis (fat expansion), and inflammation within the orbital tissue.
While intravenous glucocorticoids (IVGC) are the standard first-line treatment, they primarily exert broad anti-inflammatory effects and may fail to adequately suppress the tissue remodeling (adipogenesis and fibrosis) driven by these specific signaling pathways. Consequently, a significant proportion of patients become "steroid-resistant."
This study proposes the use of Tofacitinib, a small-molecule JAK inhibitor, as a targeted rescue therapy. By inhibiting the JAK-STAT pathway, Tofacitinib is hypothesized to suppress both the inflammatory cytokine release and the orbital tissue remodeling that persists despite steroid treatment.
Participants will enter a 24-week treatment phase receiving oral Tofacitinib (5 mg twice daily). Clinical assessments will be performed at Baseline, Week 4, 12, 24, and a follow-up visit at Week 36. Key exploratory components of this study include: 1. Quantitative Orbital Imaging: Use of Orbital MRI to objectively measure changes in extraocular muscle volume and orbital fat volume to distinguish between anti-inflammatory and anti-remodeling effects. 2. Durability of Response: A 12-week post-treatment observation period (Weeks 24-36) to monitor for disease relapse or "rebound" phenomena after drug cessation. 3. Safety in Comorbidities: Close monitoring of coagulation profiles and lipid levels, given the known safety profile of JAK inhibitors, specifically in this population with potential metabolic comorbidities.
- Being tested
- Tofacitinib
- Keywords
- Tofacitinib, Refractory Thyroid Eye Disease, Graves' Orbitopathy, JAK Inhibitor, Steroid-resistant, Glucocorticoid-resistant
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
5 mg tablet administered orally twice daily (BID) for a continuous period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib Treatment Group | Experimental | Participants in this arm will receive oral Tofacitinib Citrate (5 mg) twice daily (BID) for a total treatment duration of 24 weeks. Following the 24-week treatment period, participants will undergo a 12-week drug-withdrawal observation phase to monitor for disease relapse and safety. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Percentage of participants classified as responders in the study eye. A responder is defined as a patient who achieves at least one of the following criteria without deterioration in the fellow eye: (1) Reduction in proptosis>=2 mm; (2) Reduction in Clinical Activity Score (CAS) >= 2 points (on a 7-point scale).
Measured: Week12，24
Secondary outcomes (5)
Change in Proptosis
Mean change in proptosis from baseline in the study eye, measured by Hertel exophthalmometer in millimeters (mm).
Measured: Baseline, Week 4, 12, 24, and 36
Change in Clinical Activity Score (CAS)
Mean change in Clinical Activity Score (CAS) from baseline. CAS is assessed on a 7-point scale (1 point for each: spontaneous retrobulbar pain, pain on gaze, eyelid erythema, eyelid swelling, conjunctival injection, chemosis, inflammation of caruncle/plica), where higher scores indicate more active inflammation.
Measured: Baseline, Week 4, 12, 24, and 36
Diplopia Response
ercentage of participants with improvement in diplopia. Improvement is defined as a reduction of at least one grade in the Gorman diplopia score (Grades: absent, intermittent, inconstant, constant)
Measured: 12W,24W
Change in Graves' Orbitopathy Quality of Life (GO-QOL) Score
Mean change in the Graves' Orbitopathy Quality of Life (GO-QOL) questionnaire score from baseline. The GO-QOL measures two subscales: visual functioning and appearance. For each subscale, the minimum score is 0 and the maximum score is 100. Higher scores indicate a better quality of life.
Measured: Baseline and Week4，12，24，36
Incidence of Adverse Events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including specific monitoring for infections, herpes zoster, venous thromboembolism, and lipid profile alterations.
Measured: From baseline through Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start24 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm, open-label study. All eligible participants will be assigned to the treatment group to receive oral Tofacitinib Citrate (5 mg, twice daily) for a duration of 24 weeks. There is no concurrent control group. Efficacy endpoints will be assessed by comparing post-treatment data with baseline measurements (self-controlled design). After the 24-week treatment phase, participants will undergo a 12-week drug-withdrawal observation period to monitor for disease relapse.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fangsen Xiao, MD, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547930
- Sponsor's protocol ID
- XMFHIIT-2026SL001
- Acronym
- TOFA-GO
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in accordance with applicable data privacy laws and institutional ethics requirements. The informed consent obtained from participants did not authorize external data sharing.
Publications
Kim W, Seo MK, Kim YJ, Choi SH, Ku CR, Kim S, Lee EJ, Yoon JS. Role of the suppressor of cytokine signaling-3 in the pathogenesis of Graves' orbitopathy. Front Endocrinol (Lausanne). 2025 Mar 4;16:1527275. doi: 10.3389/fendo.2025.1527275. eCollection 2025.
PubMed 40104138Ghahvehchian H, Eshraghi B. Tofacitinib for Refractory Thyroid Eye Disease. JAMA Ophthalmol. 2025 Dec 1;143(12):1073-1075. doi: 10.1001/jamaophthalmol.2025.3974.
PubMed 41165674Wiersinga WM, Eckstein AK, Zarkovic M. Thyroid eye disease (Graves' orbitopathy): clinical presentation, epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2025 Jul;13(7):600-614. doi: 10.1016/S2213-8587(25)00066-X. Epub 2025 May 2.
PubMed 40324443Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
PubMed 34297684
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Exploratory Study of Tofacitinib in Patients With Glucocorticoid-Resistant or Intolerant Moderate-to-Severe Active Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07547930
- Acronym / sponsor ID
- TOFA-GO / XMFHIIT-2026SL001
- Keywords
- Tofacitinib, Refractory Thyroid Eye Disease, Graves' Orbitopathy, JAK Inhibitor, Steroid-resistant, Glucocorticoid-resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Apr 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.
Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects.
This study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.
Detailed description
Thyroid Eye Disease (TED) involves complex pathogenesis where orbital fibroblasts are activated by autoantibodies targeting the TSH receptor (TSHR) and the Insulin-like Growth Factor-1 receptor (IGF-1R). Current evidence suggests that TSHR and IGF-1R form a physical and functional complex that activates downstream signaling cascades, prominently the Janus Kinase/Signal Transducer and Activator of Transcription (JAK-STAT) pathway. The activation of STAT3, in particular, is a critical driver of hyaluronan synthesis, adipogenesis (fat expansion), and inflammation within the orbital tissue.
While intravenous glucocorticoids (IVGC) are the standard first-line treatment, they primarily exert broad anti-inflammatory effects and may fail to adequately suppress the tissue remodeling (adipogenesis and fibrosis) driven by these specific signaling pathways. Consequently, a significant proportion of patients become "steroid-resistant."
This study proposes the use of Tofacitinib, a small-molecule JAK inhibitor, as a targeted rescue therapy. By inhibiting the JAK-STAT pathway, Tofacitinib is hypothesized to suppress both the inflammatory cytokine release and the orbital tissue remodeling that persists despite steroid treatment.
Participants will enter a 24-week treatment phase receiving oral Tofacitinib (5 mg twice daily). Clinical assessments will be performed at Baseline, Week 4, 12, 24, and a follow-up visit at Week 36. Key exploratory components of this study include: 1. Quantitative Orbital Imaging: Use of Orbital MRI to objectively measure changes in extraocular muscle volume and orbital fat volume to distinguish between anti-inflammatory and anti-remodeling effects. 2. Durability of Response: A 12-week post-treatment observation period (Weeks 24-36) to monitor for disease relapse or "rebound" phenomena after drug cessation. 3. Safety in Comorbidities: Close monitoring of coagulation profiles and lipid levels, given the known safety profile of JAK inhibitors, specifically in this population with potential metabolic comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm, open-label study. All eligible participants will be assigned to the treatment group to receive oral Tofacitinib Citrate (5 mg, twice daily) for a duration of 24 weeks. There is no concurrent control group. Efficacy endpoints will be assessed by comparing post-treatment data with baseline measurements (self-controlled design). After the 24-week treatment phase, participants will undergo a 12-week drug-withdrawal observation period to monitor for disease relapse.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib Treatment Group | Experimental | Drug: TofacitinibParticipants in this arm will receive oral Tofacitinib Citrate (5 mg) twice daily (BID) for a total treatment duration of 24 weeks. Following the 24-week treatment period, participants will undergo a 12-week drug-withdrawal observation phase to monitor for disease relapse and safety. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age and Gender: Male or female participants aged 18 to 75 years (inclusive).
- Diagnosis: Clinical diagnosis of Graves' orbitopathy (GO) consistent with EUGOGO criteria.
- Severity: Moderate-to-severe GO as defined by EUGOGO guidelines (impact on daily life, but not sight-threatening).
- Activity: Active disease, defined as a Clinical Activity Score (CAS) >=3 points (on the 7-point scale).
- Refractory Status (Must meet ONE of the following):Glucocorticoid-Resistant: Failure to respond (no significant improvement in proptosis or CAS) after receiving a cumulative dose of at least 3g of intravenous methylprednisolone (or equivalent).Glucocorticoid-Intolerant: Documented contraindications to high-dose systemic glucocorticoids (e.g., uncontrolled diabetes mellitus, severe osteoporosis, glaucoma, severe psychiatric disorders) or history of severe adverse events leading to discontinuation.
Key exclusion criteria (8 listed)
- 1.Sight-Threatening Disease: Presence of Dysthyroid Optic Neuropathy (DON) or severe corneal breakdown requiring immediate surgical intervention.
- 2.Chronic/Inactive Disease: Fibrotic or burnout stage of GO with a Clinical Activity Score (CAS) < 3.
- 3.Prior Orbital Treatment:Orbital radiotherapy at any time.Orbital surgical decompression at any time.Strabismus surgery or eyelid surgery within 3 months prior to baseline.
- 4.Concomitant Immunomodulation: Use of other biologic agents (e.g., Teprotumumab, Rituximab, Tocilizumab) within 3 months prior to baseline.
- 5.Active Infection Risk (Critical for JAK Inhibitors):Active tuberculosis (TB) or untreated latent TB.Active or chronic Hepatitis B or Hepatitis C infection.Human Immunodeficiency Virus (HIV) infection.History of disseminated herpes zoster or herpes simplex.Any severe active infection requiring hospitalization or IV antibiotics within 4 weeks of baseline.
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 |
|---|---|---|
| Tofacitinib5 mg tablet administered orally twice daily (BID) for a continuous period of 24 weeks. | Drug | Tofacitinib Treatment Group |
Primary outcome
Overall Response Rate (ORR)
Time frame: Week12，24
Percentage of participants classified as responders in the study eye. A responder is defined as a patient who achieves at least one of the following criteria without deterioration in the fellow eye: (1) Reduction in proptosis>=2 mm; (2) Reduction in Clinical Activity Score (CAS) >= 2 points (on a 7-point scale).
5 secondary outcomes
Change in Proptosis
Time frame: Baseline, Week 4, 12, 24, and 36
Change in Clinical Activity Score (CAS)
Time frame: Baseline, Week 4, 12, 24, and 36
Diplopia Response
Time frame: 12W,24W
Change in Graves' Orbitopathy Quality of Life (GO-QOL) Score
Time frame: Baseline and Week4，12，24，36
Incidence of Adverse Events
Time frame: From baseline through Week 36
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 29 Apr 2026.
- Background: PubMed 40104138Kim W, Seo MK, Kim YJ, Choi SH, Ku CR, Kim S, Lee EJ, Yoon JS. Role of the suppressor of cytokine signaling-3 in the pathogenesis of Graves' orbitopathy. Front Endocrinol (Lausanne). 2025 Mar 4;16:1527275. doi: 10.3389/fendo.2025.1527275. eCollection 2025.
- Background: PubMed 41165674Ghahvehchian H, Eshraghi B. Tofacitinib for Refractory Thyroid Eye Disease. JAMA Ophthalmol. 2025 Dec 1;143(12):1073-1075. doi: 10.1001/jamaophthalmol.2025.3974.
- Background: PubMed 40324443Wiersinga WM, Eckstein AK, Zarkovic M. Thyroid eye disease (Graves' orbitopathy): clinical presentation, epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2025 Jul;13(7):600-614. doi: 10.1016/S2213-8587(25)00066-X. Epub 2025 May 2.
- Background: PubMed 34297684Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
- Individual participant dataSharing planned: No. IPD will not be shared in accordance with applicable data privacy laws and institutional ethics requirements. The informed consent obtained from participants did not authorize external data sharing.
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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.
Fangsen Xiao, MD principal investigator
The First Affiliated Hospital of Xiamen University
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 Tofacitinib in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by The First Affiliated Hospital of Xiamen 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 8 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
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 Fangsen Xiao, MD (+86-592-2137710, xfs888@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Week12，24). 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 NCT07547930, which also lists 4 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 29 Apr 2026.