Locally Advanced Sinonasal CarcinomaPhase 2PANDANCT07645846
Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma
A Phase 2 study testing Neoadjuvant Chemo-Immunotherapy in people with Locally Advanced Sinonasal Carcinoma, run by Sun Yat-sen University.
Trial summary
The main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Sinonasal Carcinoma
- What is being tested?
- Neoadjuvant Chemo-Immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 1 Aug 2030
- 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
- Disease Status: Newly diagnosed, pathologically confirmed locally advanced (AJCC 8th edition Stage III-IVA) sinonasal carcinoma (SNC).
- Suitable for radical comprehensive treatment, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- 18 to 75 years old.
- Defined by the following laboratory test results obtained within 7 days prior to enrollment: Hematology (without blood transfusion or hematopoietic growth factor therapy within 14 days prior to testing): White blood cell (WBC) count ≥ 4.0 × 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L; Platelet (PLT) count ≥ 100 × 10^9/L.
- Hepatic function: Total bilirubin < 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible); Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase < 1.5 × ULN. For patients positive for hepatitis B surface antigen (HBsAg), HBV-DNA must be ≤ 1000 IU/mL, and prophylactic antiviral therapy is required during the study.
- Renal function: Serum creatinine < 1.5 × ULN, or creatinine clearance ≥ 60 mL/min as calculated by the Cockcroft-Gault formula.
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- Coagulation: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN. Patients receiving stable doses of anticoagulant therapy (e.g., low molecular weight heparin or warfarin) with an INR within the expected therapeutic range are eligible.
- Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels will be evaluated, and patients with normal T3 and T4 levels are eligible.
- Contraception: Women of childbearing potential must agree to use highly effective contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the treatment period and for at least 3 months after the last dose. They must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating. Male patients must agree to use highly effective contraceptive measures during the study period and for at least 3 months after the last dose.
- Informed Consent: Voluntary participation with written informed consent signed.
Who cannot join
- History of other malignancies within the past 5 years, except for curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Presence of residual measurable lesions or new tumor/metastasis according to RECIST 1.1 criteria, or deemed inoperable by a head and neck surgeon.
- History of severe hypersensitivity reactions to other monoclonal antibodies or any components of the PD-1 inhibitors.
- Prior and Concomitant Therapies: Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation or checkpoint pathways).
- Use of high-dose glucocorticoids or traditional Chinese medicine with anti-tumor properties within 4 weeks prior to the first dose of the study drug.
- Prior vaccination with an anti-tumor vaccine, or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug.
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- Receipt of any investigational drug within 4 weeks prior to the first dose of the study drug.
- Presence of comorbidities requiring long-term immunosuppressive therapy, or requiring systemic or local administration of corticosteroids at immunosuppressive doses prior to enrollment.
- Concurrent Trials: Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
- Recent Medical Events: Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.
- Organ Transplantation: History of organ transplantation.
- Autoimmune Diseases: Known or suspected active autoimmune disease.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
- Concurrent positive HBsAg and positive HBV DNA copy number (quantitative detection ≥ 1000 cps/mL). Positive blood screening for chronic hepatitis C (HCV antibody positive). Concurrent HBV and HCV co-infection. (Note: Patients with normal liver function who have been on oral antiviral therapy for more than one week may be eligible).
- Failure to meet relevant laboratory criteria within 7 days prior to enrollment; abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5 g/L), bleeding tendency, or undergoing active thrombolytic or anticoagulant therapy.
- Significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function. History of dementia or seizures.
- Severe Infections: Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging indicating active pulmonary inflammation; presence of signs and symptoms of infection within 2 weeks prior to the first dose of the study drug, or requiring oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics).
- Pregnancy and Lactation: Pregnant or lactating women; women of childbearing potential who refuse to use effective contraceptive measures.
- Compliance and Legal Capacity: Refusal or inability to sign the informed consent form; presence of personality or psychiatric disorders; lack of or limited civil capacity.
- Other: Presence of any other treatment contraindications deemed inappropriate by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaoyun Feng contact
About this study
Official title: A Multicenter, Single-Arm, Phase II Trial of Neoadjuvant Docetaxel and Cisplatin Combined With Dual Immunotherapy for Locally Advanced Sinonasal Carcinoma (PANDA Study)
The main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). The treatment consists of the standard TP chemotherapy regimen (docetaxel and cisplatin) combined with dual immunotherapy (sintilimab and ipilimumab N01) administered before surgery. Researchers aim to determine the major pathological response (MPR) rate and long-term survival outcomes, while also exploring if this combination treatment approach can help better preserve critical facial and organ functions for SNC patients.
Read the detailed description
Currently, there is a lack of prospective phase II/III clinical evidence to guide the optimal treatment of locally advanced sinonasal carcinoma (SNC). Based on current clinical guidelines for head and neck squamous cell carcinoma (HNSCC), the investigators hypothesize that the combination of TP chemotherapy with dual immune checkpoint inhibitors (targeting PD-1 and CTLA-4) could significantly improve the major pathological response (MPR) and achieve superior organ function preservation in patients with locally advanced SNC.
By evaluating the TP regimen combined with sintilimab and ipilimumab N01, this trial seeks to validate the feasibility of organ function preservation under this therapeutic modality. If successful, this treatment strategy will establish a novel precision treatment paradigm that effectively balances tumor control with organ function preservation, laying a solid foundation for subsequent phase III randomized controlled trials.
- Conditions
- Locally Advanced Sinonasal Carcinoma
- Being tested
- Neoadjuvant Chemo-Immunotherapy
- Keywords
- Locally Advanced, Sinonasal Carcinoma, neoadjuvant therapy, dual immune checkpoint inhibitors, Docetaxel, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemo-ImmunotherapyDrug
Drug: Ipilimumab N01, 1mg/kg, D1C1.
Drug: Sintilimab, 200mg, Q3W, C1C2C3.
Drug: Docetaxel, 75mg/m2, Q3W, C1C2C3.
Drug: Cisplatin, 60mg/m2, Q3W, C1C2C3.
Procedure: Radical Surgery.
Radiation: Adjuvant Radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemo-Immunotherapy | Experimental | Patients will receive neoadjuvant therapy consisting of Ipilimumab N01 (1 mg/kg, IV, Day 1 of Cycle 1), Sintilimab (200 mg, IV, Q3W for 3 cycles), Docetaxel (75 mg/m^2, IV, Q3W for 3 cycles), and Cisplatin (60 mg/m^2, IV, Q3W for 3 cycles). Radical surgery will be performed within 4 weeks after the completion of neoadjuvant therapy. Postoperative adjuvant radiotherapy with or without chemotherapy will be determined by the investigators and a multidisciplinary team (MDT) based on NCCN and CSCO guidelines. Receives: Drug: Neoadjuvant Chemo-Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate(MPR)
Defined as the percentage of participants whose resected tumor specimens show ≤10% viable tumor cells upon microscopic examination following neoadjuvant therapy.
Measured: From enrollment to the end of treatment at 9 weeks
Secondary outcomes (10)
Objective Response Rate (ORR)
Defined as the proportion of patients who achieve a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 2 years
2-Year Overall Survival (OS) Rate
Defined as the percentage of participants who are alive 2 years after the initiation of treatment.
Measured: 2 years from the start of treatment
Median Overall Survival (mOS)
Defined as the time from the start of treatment to death from any cause in 50% of the evaluated patients.
Measured: Up to 2 years
2-Year Progression-Free Survival (PFS) Rate
Defined as the percentage of participants who remain alive and free of disease recurrence, new metastasis, or disease progression 2 years after the completion of the last treatment.
Measured: 2 years from the end of the last treatment
Median Progression-Free Survival (mPFS)
Defined as the time from the start of treatment until disease progression or death in 50% of the evaluable patients.
Measured: Up to 2 years
Duration of Response (DoR)
Evaluated per RECIST v1.1.
Measured: From the first documented CR or PR until the first documented tumor progression or death from any cause, assessed up to 2 years
Disease Control Rate (DCR)
Defined as the percentage of patients who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment.
Measured: Up to 2 years
R0 Resection Rate
Defined as the percentage of patients achieving a complete tumor resection with microscopically negative margins.
Measured: At the time of surgery (assessed up to 4 weeks after completion of neoadjuvant therapy)
Organ Functional Preservation Rate (OFPR)
Defined as the percentage of living patients at 2 years post-treatment who do not require salvage radical surgery and successfully preserve major physiological functions. Patients must meet all 4 conditions:
Maxilla \& Oral: No total maxillectomy (limited/scaffold-preserving excision allowed); no permanent tube feeding; intelligible speech; no severe trismus (mouth opening >2.5cm).
Orbit \& Vision: No enucleation/orbital exenteration; ipsilateral vision better than light perception (≥0.05); no intractable diplopia, severely restricted eye movement, or eyelid dysfunction causing exposure keratitis.
Skull Base \& Neurological: No massive cranial/dural defect from extensive resection; no persistent CSF leak; no severe treatment-induced CNS complications.
Appearance: No obvious facial collapse or disfigurement; adequate subjective satisfaction (FACE-Q scale); no external facial prosthesis required.
Measured: At 2 years post-treatment
Change in Quality of Life Scores (QOL)
The psychological state and overall quality of life of the patients will be evaluated using the QOL-V30 questionnaire. Higher scores generally represent a higher quality of life or level of functioning.
Measured: Baseline and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start31 Jul 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Sinonasal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- A Simon's two-stage minimax design is adopted for this single-arm study to evaluate the efficacy and safety of the neoadjuvant combination therapy.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, Qingyuan People's Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Chen Chunyan, Sun Yat-sen University
- Investigators
- Xuekui Liu, Principal investigator, Sun Yat-Sen University Cancer CenterChunyan Chen, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645846
- Sponsor's protocol ID
- 2026-FXY-123
- Acronym
- PANDA
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the publication will be shared. Study protocol and statistical analysis plan will also be available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase II Trial of Neoadjuvant Docetaxel and Cisplatin Combined With Dual Immunotherapy for Locally Advanced Sinonasal Carcinoma (PANDA Study)
- ClinicalTrials.gov ID
- NCT07645846
- Acronym / sponsor ID
- PANDA / 2026-FXY-123
- Conditions
- Locally Advanced Sinonasal Carcinoma
- Keywords
- Locally Advanced, Sinonasal Carcinoma, neoadjuvant therapy, dual immune checkpoint inhibitors, Docetaxel, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, Qingyuan People's Hospital, Guangdong Provincial People's Hospital
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 12 Jun 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 main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). The treatment consists of the standard TP chemotherapy regimen (docetaxel and cisplatin) combined with dual immunotherapy (sintilimab and ipilimumab N01) administered before surgery. Researchers aim to determine the major pathological response (MPR) rate and long-term survival outcomes, while also exploring if this combination treatment approach can help better preserve critical facial and organ functions for SNC patients.
Detailed description
Currently, there is a lack of prospective phase II/III clinical evidence to guide the optimal treatment of locally advanced sinonasal carcinoma (SNC). Based on current clinical guidelines for head and neck squamous cell carcinoma (HNSCC), the investigators hypothesize that the combination of TP chemotherapy with dual immune checkpoint inhibitors (targeting PD-1 and CTLA-4) could significantly improve the major pathological response (MPR) and achieve superior organ function preservation in patients with locally advanced SNC.
By evaluating the TP regimen combined with sintilimab and ipilimumab N01, this trial seeks to validate the feasibility of organ function preservation under this therapeutic modality. If successful, this treatment strategy will establish a novel precision treatment paradigm that effectively balances tumor control with organ function preservation, laying a solid foundation for subsequent phase III randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Simon's two-stage minimax design is adopted for this single-arm study to evaluate the efficacy and safety of the neoadjuvant combination therapy.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemo-Immunotherapy | Experimental | Drug: Neoadjuvant Chemo-ImmunotherapyPatients will receive neoadjuvant therapy consisting of Ipilimumab N01 (1 mg/kg, IV, Day 1 of Cycle 1), Sintilimab (200 mg, IV, Q3W for 3 cycles), Docetaxel (75 mg/m^2, IV, Q3W for 3 cycles), and Cisplatin (60 mg/m^2, IV, Q3W for 3 cycles). Radical surgery will be performed within 4 weeks after the completion of neoadjuvant therapy. Postoperative adjuvant radiotherapy with or without chemotherapy will be determined by the investigators and a multidisciplinary team (MDT) based on NCCN and CSCO guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Disease Status: Newly diagnosed, pathologically confirmed locally advanced (AJCC 8th edition Stage III-IVA) sinonasal carcinoma (SNC).
- Suitable for radical comprehensive treatment, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- 18 to 75 years old.
- Defined by the following laboratory test results obtained within 7 days prior to enrollment: Hematology (without blood transfusion or hematopoietic growth factor therapy within 14 days prior to testing): White blood cell (WBC) count ≥ 4.0 × 10^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L; Platelet (PLT) count ≥ 100 × 10^9/L.
- Hepatic function: Total bilirubin < 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible); Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase < 1.5 × ULN. For patients positive for hepatitis B surface antigen (HBsAg), HBV-DNA must be ≤ 1000 IU/mL, and prophylactic antiviral therapy is required during the study.
Key exclusion criteria (20 listed)
- History of other malignancies within the past 5 years, except for curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Presence of residual measurable lesions or new tumor/metastasis according to RECIST 1.1 criteria, or deemed inoperable by a head and neck surgeon.
- History of severe hypersensitivity reactions to other monoclonal antibodies or any components of the PD-1 inhibitors.
- Prior and Concomitant Therapies: Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation or checkpoint pathways).
- Use of high-dose glucocorticoids or traditional Chinese medicine with anti-tumor properties within 4 weeks prior to the first dose of the study drug.
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 |
|---|---|---|
| Neoadjuvant Chemo-ImmunotherapyDrug: Ipilimumab N01, 1mg/kg, D1C1. Drug: Sintilimab, 200mg, Q3W, C1C2C3. Drug: Docetaxel, 75mg/m2, Q3W, C1C2C3. Drug: Cisplatin, 60mg/m2, Q3W, C1C2C3. Procedure: Radical Surgery. Radiation: Adjuvant Radiotherapy. | Drug | Neoadjuvant Chemo-Immunotherapy |
Primary outcome
Major Pathological Response Rate(MPR)
Time frame: From enrollment to the end of treatment at 9 weeks
Defined as the percentage of participants whose resected tumor specimens show ≤10% viable tumor cells upon microscopic examination following neoadjuvant therapy.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
2-Year Overall Survival (OS) Rate
Time frame: 2 years from the start of treatment
Median Overall Survival (mOS)
Time frame: Up to 2 years
2-Year Progression-Free Survival (PFS) Rate
Time frame: 2 years from the end of the last treatment
Median Progression-Free Survival (mPFS)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: From the first documented CR or PR until the first documented tumor progression or death from any cause, assessed up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
R0 Resection Rate
Time frame: At the time of surgery (assessed up to 4 weeks after completion of neoadjuvant therapy)
Organ Functional Preservation Rate (OFPR)
Time frame: At 2 years post-treatment
Change in Quality of Life Scores (QOL)
Time frame: Baseline and up to 2 years
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 25 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the publication will be shared. Study protocol and statistical analysis plan will also be available.
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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.
Xiaoyun Feng contact
Xuekui Liu principal investigator
Sun Yat-Sen University Cancer Center
Chunyan Chen principal investigator
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemo-Immunotherapy in people with Locally Advanced Sinonasal Carcinoma, run by Sun Yat-sen University.
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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kaiyue Mao (86-020-87342926, maokaiyue@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate(MPR) (time frame: From enrollment to the end of treatment at 9 weeks). 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 25 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.