Locally Advanced Esophageal Squamous Cell CarcinomaPhase 1/2NCT05743504
Immunotherapy With CCRT Followed by Surgery for Locally Advanced ESCC Patients
A Phase 1/2 study testing Tiragolumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The prognosis of ESCC is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that TMT, consisted of neoadjuvant concurrent CCRT and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Tiragolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Sep 2023to 30 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proved squamous cell carcinoma of esophagus
- Locally advanced disease, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition) in 2017, fulfilling one of the following criteria:
- T1-2N2-3M0
- T3N1-3M0
- Tumor judged to be operable and resectable with curative intent on the screening assessment
- Age ≥ 20 years
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- Medical fit for curative surgery
- ECOG Performance Status 0 or 1
- Adequate bone marrow reserves within 2 weeks prior to registration, defined as:
- absolute neutrophil count (ANC) ≥ 1.5×109/L (1,500/μl)
- platelets ≥ 100×109/L (100,000/µl)
- hemoglobin ≥ 9.0 g/dl (may have been transfused)
- Adequate liver function reserves within 2 weeks prior to registration, defined as:
- hepatic transaminases (AST and ALT) ≤ 2.5 × upper limit of normal (ULN)
- serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Adequate renal function within 2 weeks prior to registration: Creatinine ≤1.5 mg/dL
- Negative hepatitis B surface antigen (HBsAg) at screening or Positive HBsAg with HBV DNA < 500 IU/mL (or 2500 copies/mL) at screening. Patients with detectable HBsAg or detectable HBV DNA should be managed institutional guidelines.
- Patients receiving anti-viral medication must have initiated treatment at least 2 weeks prior to protocol treatment and should continue treatment for at least 6 months after the final dose of study treatment
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Negative serum or urine pregnancy test for women of childbearing potential
- Women of childbearing potential and male participants must practice highly effective contraception with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 90 days after the final dose of tiragolumab
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Who cannot join
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-¬CTLA-4, anti-PD-1, anti-PD-L1 and anti-¬TIGIT therapeutic antibodies
- Prior radiotherapy to head and neck, chest, or abdomen
- Prior chemotherapy
- Histology consistent with adenocarcinoma, small cell carcinoma or mixed carcinoma of esophagus or gastroesophageal junction.
- Synchronously or metachronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer
- History of malignancy other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
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- Patients who received endoscopic mucosal resection or dissection for superficial mucosal cancers other than ESCC within 2 years prior to screening are eligible for the study.
- Prior organ transplantation including allogenic stem-cell transplantation
- Current use of immunosuppressive medication, EXCEPT for the following:
- intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
- systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
- steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to registration
- Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment and on stable regimen are eligible.
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
- Severe infection within 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to registration. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
- Transmural myocardial infarction < 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization < 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- Cerebral vascular accident/stroke (< 6 months prior to enrollment)
- Congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness including pulmonary fibrosis requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled psychiatric disorder including recent (within the past year) or active suicidal ideation or behavior
- Laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results
- Immune colitis, inflammatory bowel disease, immune pneumonitis
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan
- Active tuberculosis
- Uncontrolled or symptomatic hypercalcemia (corrected calcium > ULN)
- Known history of testing positive for HIV or known acquired immunodeficiency syndrome."
- Positive Epstein-Barr virus (EBV) viral capsid antigen IgM test at screening
- An EBV polymerase chain reaction (PCR) test should be performed as clinically indicated to screen for active infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded.
- Vaccination with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment is prohibited except for administration of inactivated vaccines
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known prior severe hypersensitivity to investigational product, Chinese hamster ovary cell products or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)
- Concurrent participation in another interventional clinical trial
- Pregnant or breast-feeding women
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chia-Hsien Cheng, M.D., M.S., Ph.D., FASTRO, +886-2-2352-2846, jasoncheng@ntuh.edu.tw
Chia-Hsien Cheng, PhD
About this study
Official title: A Phase Ib/II Trial of Neoadjuvant Tiragolumab, Atezolizumab, Paclitaxel, Cisplatin and Radiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
The prognosis of ESCC is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that TMT, consisted of neoadjuvant concurrent CCRT and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. As a consequence, it is mandatory to develop new pharmacotherapeutic regimen for TMT. In our previous prospective studies, we found higher levels of serum immune-related biomarkers, VEGF-A, TGF-β1, and soluble PD-L1, before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy. In the present clinical trial, we plan to investigate whether incorporation of tiragolumab (Anti-TIGIT) and atezolizumab (Anti-PD-L1) into standard TMT will be safe while improve the pathological complete response rate. By the present research, we expect to develop a new TMT regimen for this poor prognostic disease.
Read the detailed description
Esophageal squamous cell carcinoma (ESCC) is one of the most lethal malignancy worldwide. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. Despite of the advancement, the outcome remained unsatisfactory with the median recurrence-free survival around 20 to 25 months and median overall survival around 30 months. It is known that the most important prognostic factor is whether a pathological complete response can be achieved after neoadjuvant CCRT. However, the use of new generation chemotherapeutic agent and epidermal growth factor inhibitors failed to significantly improve prognosis comparing to the standard platinum-based regimen. As a consequence, it is mandatory to develop new pharmacotherapeutic regimen for TMT.
In our previous prospective studies, we found higher levels of serum immune-related biomarkers, VEGF-A, TGF-β1, and soluble PD-L1, before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy. Recent clinical trials have shown the efficacy of anti-PD-1 in recurrent/metastatic ESCC. Besides, preclinical and clinical studies suggested radiotherapy might induce local inflammatory stimulus for the immune modulating drug to boost the integrated response. In addition, preclinical study showed promising anti-cancer efficacy by combination of fractionated radiotherapy, anti-PD-L1 and/or anti-TIGIT immunotherapy. Though several prospective clinical trials have shown the feasibility, safety, and activity of adding anti-TIGIT therapy to anti-PD-L1 drug, and adding anti-PD-L1 therapy to chemotherapy in lung cancer, the safety and activity of combing anti-PD-1/PD-L1 to CCRT or TMT remained largely undetermined. In the present clinical trial, we plan to investigate whether incorporation of tiragolumab (Anti-TIGIT) and atezolizumab (Anti-PD-L1) into standard TMT will be safe while improve the pathological complete response rate. By the present research, we expect to develop a new TMT regimen for this poor prognostic disease.
This study is a single arm open labeled trial to evaluate the safety and pathological response of ESCC patients receiving neoadjuvant Paclitaxel/Cisplatin(TP)-CCRT plus Tiragolumab/Atezolizumab followed by radical esophagectomy. We design to enroll 32 patients to develop the preliminary evidence for incorporating tiragolumab/atezolizumab in locally advanced ESCC.
- Being tested
- Tiragolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiragolumabDrug
Also called Atezolizumab, Paclitaxel, Cisplatin, Radiotherapy
Neoadjuvant Tiragolumab, Atezolizumab, Paclitaxel, Cisplatin and Radiotherapy Followed by Surgery
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy with CCRT before surgery | Experimental | Tiragolumab and Atezolizumab with CCRT before surgery Receives: Drug: Tiragolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Pathological complete response rate after radical esophagectomy with or without adding tiragolumab/atezolizumab to neoadjuvant paclitaxel-platinum concurrent chemoradiation
Measured: Through study treatment, around 4 to 5 months
Secondary outcomes (7)
Side effect evaluation
major morbidity rate after completion of protocol treatment
Measured: 30 days
Side effect evaluation
major mortality rate after completion of protocol treatment
Measured: 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Acute toxicities occurred will be collected and evaluated by NCI CTCAE v5.0
Measured: Within 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Late toxicities occurred will be collected and evaluated by NCI CTCAE v5.0
Measured: over 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Immune-mediated toxicities will be evaluated by NCI CTCAE v5.0
Measured: Less than 90 days from last tiragolumab/atezolizumab administration
Number of participants with surgical complications
Surgical complications categorized by the Clavien classification
Measured: within 1 months after radical esophagectomy performed.
Number of participants with delay in planned radical esophagectomy
Delay in planned radical esophagectomy
Measured: surgery performed ( 12 weeks after IO-CCRT completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start18 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsien Cheng, Cheng, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743504
- Sponsor's protocol ID
- 202111099MIPC
- Other IDs
- ML43431
- Status last verified
- Sep 2023
- First submitted
- 30 Jan 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Trial of Neoadjuvant Tiragolumab, Atezolizumab, Paclitaxel, Cisplatin and Radiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05743504
- Acronym / sponsor ID
- 202111099MIPC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 24 Feb 2023 (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 prognosis of ESCC is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that TMT, consisted of neoadjuvant concurrent CCRT and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. As a consequence, it is mandatory to develop new pharmacotherapeutic regimen for TMT. In our previous prospective studies, we found higher levels of serum immune-related biomarkers, VEGF-A, TGF-β1, and soluble PD-L1, before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy. In the present clinical trial, we plan to investigate whether incorporation of tiragolumab (Anti-TIGIT) and atezolizumab (Anti-PD-L1) into standard TMT will be safe while improve the pathological complete response rate. By the present research, we expect to develop a new TMT regimen for this poor prognostic disease.
Detailed description
Esophageal squamous cell carcinoma (ESCC) is one of the most lethal malignancy worldwide. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival for patients with resectable locally advanced disease. Despite of the advancement, the outcome remained unsatisfactory with the median recurrence-free survival around 20 to 25 months and median overall survival around 30 months. It is known that the most important prognostic factor is whether a pathological complete response can be achieved after neoadjuvant CCRT. However, the use of new generation chemotherapeutic agent and epidermal growth factor inhibitors failed to significantly improve prognosis comparing to the standard platinum-based regimen. As a consequence, it is mandatory to develop new pharmacotherapeutic regimen for TMT.
In our previous prospective studies, we found higher levels of serum immune-related biomarkers, VEGF-A, TGF-β1, and soluble PD-L1, before neoadjuvant CCRT were independent associated with inferior overall survival and disease-free survival for locally advanced ESCC treated with neoadjuvant CCRT plus radical esophagectomy. Recent clinical trials have shown the efficacy of anti-PD-1 in recurrent/metastatic ESCC. Besides, preclinical and clinical studies suggested radiotherapy might induce local inflammatory stimulus for the immune modulating drug to boost the integrated response. In addition, preclinical study showed promising anti-cancer efficacy by combination of fractionated radiotherapy, anti-PD-L1 and/or anti-TIGIT immunotherapy. Though several prospective clinical trials have shown the feasibility, safety, and activity of adding anti-TIGIT therapy to anti-PD-L1 drug, and adding anti-PD-L1 therapy to chemotherapy in lung cancer, the safety and activity of combing anti-PD-1/PD-L1 to CCRT or TMT remained largely undetermined. In the present clinical trial, we plan to investigate whether incorporation of tiragolumab (Anti-TIGIT) and atezolizumab (Anti-PD-L1) into standard TMT will be safe while improve the pathological complete response rate. By the present research, we expect to develop a new TMT regimen for this poor prognostic disease.
This study is a single arm open labeled trial to evaluate the safety and pathological response of ESCC patients receiving neoadjuvant Paclitaxel/Cisplatin(TP)-CCRT plus Tiragolumab/Atezolizumab followed by radical esophagectomy. We design to enroll 32 patients to develop the preliminary evidence for incorporating tiragolumab/atezolizumab in locally advanced ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy with CCRT before surgery | Experimental | Drug: TiragolumabTiragolumab and Atezolizumab with CCRT before surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically proved squamous cell carcinoma of esophagus
- Locally advanced disease, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition) in 2017, fulfilling one of the following criteria:
- Tumor judged to be operable and resectable with curative intent on the screening assessment
- Age ≥ 20 years
- Medical fit for curative surgery
Key exclusion criteria (39 listed)
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-¬CTLA-4, anti-PD-1, anti-PD-L1 and anti-¬TIGIT therapeutic antibodies
- Prior radiotherapy to head and neck, chest, or abdomen
- Prior chemotherapy
- Histology consistent with adenocarcinoma, small cell carcinoma or mixed carcinoma of esophagus or gastroesophageal junction.
- Synchronously or metachronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer
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 |
|---|---|---|
| TiragolumabAlso: Atezolizumab, Paclitaxel, Cisplatin, RadiotherapyNeoadjuvant Tiragolumab, Atezolizumab, Paclitaxel, Cisplatin and Radiotherapy Followed by Surgery | Drug | Immunotherapy with CCRT before surgery |
Primary outcome
Pathological complete response rate
Time frame: Through study treatment, around 4 to 5 months
Pathological complete response rate after radical esophagectomy with or without adding tiragolumab/atezolizumab to neoadjuvant paclitaxel-platinum concurrent chemoradiation
7 secondary outcomes
Side effect evaluation
Time frame: 30 days
Side effect evaluation
Time frame: 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Within 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: over 30 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Less than 90 days from last tiragolumab/atezolizumab administration
Number of participants with surgical complications
Time frame: within 1 months after radical esophagectomy performed.
Number of participants with delay in planned radical esophagectomy
Time frame: surgery performed ( 12 weeks after IO-CCRT completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hsien Cheng, Cheng principal investigator
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tiragolumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 22 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hsien Cheng, c (+886-2-2352-2846, jasoncheng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: Through study treatment, around 4 to 5 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 2 Feb 2024.