Bladder CancerPhase 3NCT06364904
A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.
A Phase 3 study testing Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib and Tislelizumab, Cisplatin, Gemcitabine in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 8 sites in China.
Trial summary
The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib and Tislelizumab, Cisplatin, Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 8 sitesChina
- Study dates
- Oct 2025to 15 Apr 2029
- Phase
- Phase 3
- 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
- Voluntarily participate in this study, able to provide written informed consent and can understand and agree to comply with the requirements of the study and schedule of assessments.
- Participants diagnosed histologically or cytologically with locally advanced or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter, bladder, or urethra. Eligible subjects for inclusion are those with a mixed histologic type, as assessed by the investigator, with urothelial component >50% and plasmacytoid subtype <10%. Patients with histologically confirmed and radiologically assessed locally advanced or metastatic urothelial carcinoma of the urinary tract.
- Participants judged by the investigator to be tolerant of platinum-based therapy. Participants intolerant to platinum chemotherapy must meet at least one of the following criteria: ECOG performance status >1 or Karnofsky performance status 60% to 70%; creatinine clearance less than 60 ml/min; hearing loss ≥ Grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5; peripheral neuropathy ≥ Grade 2 according to NCI-CTCAE version 5; New York Heart Association Class III or IV heart failure.
- Must provide surgical or biopsy tumor tissue samples, and concurrent submission of relevant pathology reports is required. Participants are able to submit fresh surgical tissue or submit pathology slides for examination.
- ECOG Performance Status 0 or 1
- The participants must have well-functioning organ systems, as measured by the following screening laboratory values (obtained within ≤14 days before enrollment):
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- When screening for the following parameters, participants must not have used growth factor support within ≤14 days before sample collection: i. Neutrophil absolute count ≥ 1.5x10^9/L ii. Platelets ≥ 90x10^9/L iii. Hemoglobin ≥ 90g/L b. International normalized ratio or activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN) c. Calculated creatinine clearance ≥ 50 mL/min d. Serum total bilirubin ≤ 1.5×ULN (if Gilbert's syndrome or indirect bilirubin concentration indicates extrahepatic elevation, should be ≤ 3×ULN) e. AST, ALT, and alkaline phosphatase ≤ 2.5×ULN
- Women who are not pregnant or not of childbearing potential must be willing to use effective contraception during the study and for ≥120 days after the last dose of toripalimab monotherapy or chemotherapy (whichever occurs later). Additionally, they must have a negative urine or serum pregnancy test result within ≤7 days before enrollment. Non-sterilized men must be willing to use effective contraception during the study and for ≥120 days after the last dose of toripalimab monotherapy or chemotherapy (whichever occurs later).
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at least one participant with measurable lesions is required.
- Participants with an expected survival of ≥3 months.
Who cannot join
- Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. For patients with previously treated brain metastases, enrollment is not allowed if there has been CNS disease stability for at least 4 weeks before the first dose of study treatment and discontinuation of corticosteroid therapy for brain metastases for at least 2 weeks before the start of study treatment.
- Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, or other agents specifically targeting T-cell co-stimulation or checkpoint pathways.
- Receipt of other approved systemic anticancer therapy or systemic immunomodulatory agents (including but not limited to interferons, interleukins, and tumor necrosis factor) within 28 days before enrollment.
- Prior radiotherapy for bladder cancer.
- Prior systemic treatment for tumors, except:
- For patients previously treated with systemic chemotherapy, a treatment-free interval of at least 12 months from the last treatment to the start of drug treatment.
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- Local intravesical chemotherapy or immunotherapy, completed at least 1 week before the start of study treatment.
- Major surgery or significant trauma within 28 days before enrollment (placement of vascular access device and transurethral resection of bladder tumor [TURBT] are not considered major surgery).
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before enrollment (HBV infection is excluded according to exclusion criterion 11).
- Receipt of live vaccines within 28 days before enrollment (seasonal injections of influenza vaccine are usually inactivated vaccines and are allowed. Nasal vaccines are live vaccines and are not allowed).
- Active autoimmune diseases requiring systemic treatment, as determined by the investigator, which could affect the safety of study treatment.
- Long-term use of high-dose steroids or other immunosuppressive agents, as determined by the investigator, which could affect the safety of study treatment.
- Known potassium, sodium, calcium abnormalities, or hypoalbuminemia, interstitial lung disease, non-infectious pneumonia, or other uncontrolled systemic diseases, including diabetes, hypertension, cardiovascular diseases (e.g., active cardiac disease within 6 months before enrollment, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and requiring medication for ventricular arrhythmias).
- Untreated chronic hepatitis B patients with HBV DNA ≥500 IU/mL (2500 copies/mL) or HBV carriers are not eligible. Note: Patients with inactive hepatitis B surface antigen carriers or stable active HBV infection (HBV DNA <500 IU/mL [2500 copies/mL]) after continuous antiviral treatment can be enrolled. HBV DNA testing is performed only in patients positive for antibodies to the hepatitis B core antigen.
- Patients with active hepatitis C are not eligible. Patients who test negative for HCV antibodies during the screening period or, if positive, test negative for HCV RNA after positive HCV antibody testing can be enrolled. Only patients positive for HCV antibodies need HCV RNA testing.
- History of immune deficiency (including human immunodeficiency virus [HIV] positive, other acquired, congenital immunodeficiency diseases) or a history of allogeneic stem cell transplantation or organ transplantation.
- Known allergies to other monoclonal antibodies.
- Known allergies to any study drug or excipient.
- Patients with toxic side effects (due to any treatment) that have not returned to baseline or a stable level, unless the investigator does not believe that such toxic side effects may pose a safety risk (e.g., hair loss, neurologic symptoms, and specific laboratory abnormalities).
- Underlying medical conditions, alcohol/drug abuse, or dependence that may adversely affect the administration of study drug, interpretation of results, or lead to a high risk of treatment complications.
- Concurrent participation in another therapeutic clinical study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Hunan Cancer Hospital
Changsha, Hunan
Yu Xie, Ph.D
Xiangya Hospital, Central South University
Changsha, Hunan
Xiongbing Zu, Ph.D
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Peng Wu, Ph.D
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Wenlong Zhong, Ph.D
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Junxin Chen, Ph.D
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yun Luo, Ph.D
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Ebai Xu, Ph.D
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Zheng Liu, Ph.D
About this study
Official title: A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.
The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.
- Conditions
- Bladder Cancer
- Being tested
- Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
- Keywords
- Immune Checkpoint Inhibitor, CDK4/6 Inhibitor, Cisplatin, Tislelizumab, Gemcitabine, Trilaciclib
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab, Cisplatin, Gemcitabine and TrilaciclibDrug
Chemoimmunotherapy:
- Tislelizumab: 200mg, 1x time at d1 each cycle
- Gemcitabine: 1000mg/ m2, in d1, d8 each cycle
- Cisplatin: 70 mg/m2, in d2 each cycle
- Trilaciclib: 240mg/m2, d1, d2, d8 each cycle
Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
Tislelizumab, Cisplatin, GemcitabineDrug
Chemoimmunotherapy:
- Tislelizumab: 200mg, 1x time at d1 each cycle
- Gemcitabine: 1000mg/ m2, in d1, d8 each cycle
- Cisplatin: 70 mg/m2, in d2 each cycle
Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus Cisplatin | Active comparator | During each 21 days study cycle(up to 6 cycles), all participants will receive:
1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug.
2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug.
3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug.
Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed. Receives: Drug: Tislelizumab, Cisplatin, Gemcitabine |
| Gemcitabine, Cisplatin plus Trilaciclib | Experimental | During each 21 days study cycle(up to 6 cycles), all participants will receive:
1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug.
2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug.
3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug.
4. Trilaciclib: d1, d2, d8 each cycle or until it is determined participant must stop the drug.
Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed. Receives: Drug: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression-Free Survival(PFS)
Progression free survival was determined from start date of treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at the date of last disease evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: 24 months
Percentage of Participants With Incidence of Grade 3/4 Neutropenia
The proportion of participant with neutrophils with values < 1*10^9/L during treatment.
Measured: Within 28 days of initial dosing
Secondary outcomes (6)
Rate of ORR
The responses rate (PR+CR) in participants based on imaging [CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)]
Measured: 60 months
overall survival (OS)
OS was measured from the date the participant started study to death for any reason.
Measured: 60 months
Safety and AE
Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event using the Medical Dictionary for Regulatory Activities (MedDRA) terms and graded per NCI-CTCAE v5.0.
Number and Grade of patients who had a surgery-related adverse event (surgery-related AE) will be measured according to the Clavien-Dindo classification.
Measured: 60 months
Disease Control Rate(DCR)
The responses rate (PR+CR+SD) in participants based on imaging [CT scan of chest, abdomen, and pelvis (or MRI of abdomen and pelvis with CT chest without contrast when appropriate)].
Measured: 60 months
During Of Response(DOR)
During Of Response(DOR) was measured from the date from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause.
Measured: 60 months
Biomarker Endpoint Analyses
Patients' biomarkers in urine, blood, and tumor tissues (include CPS, TPS, TMB, Ki67, etc.) will be detected with the treatment of the combination of Tislelizumab with Cisplatin and Gemcitabine, with or without Trilaciclib in untreated unresectable and metastatic urothelial.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startOct 2025 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tianxin Lin, Ph.D, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364904
- Sponsor's protocol ID
- SYSKY-2024-123-02
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.
- ClinicalTrials.gov ID
- NCT06364904
- Acronym / sponsor ID
- SYSKY-2024-123-02
- Conditions
- Bladder Cancer
- Keywords
- Immune Checkpoint Inhibitor, CDK4/6 Inhibitor, Cisplatin, Tislelizumab, Gemcitabine, Trilaciclib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 15 Apr 2024 (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 aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus Cisplatin | Active comparator | Drug: Tislelizumab, Cisplatin, GemcitabineDuring each 21 days study cycle(up to 6 cycles), all participants will receive: 1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug. 2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug. 3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug. Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed. |
| Gemcitabine, Cisplatin plus Trilaciclib | Experimental | Drug: Tislelizumab, Cisplatin, Gemcitabine and TrilaciclibDuring each 21 days study cycle(up to 6 cycles), all participants will receive: 1. Tislelizumab: Taken 1x time at d1 each cycle or until it is determined participant must stop the drug. 2. Gemcitabine: d1, d8 each cycle or until it is determined participant must stop the drug. 3. Cisplatin: d2 each cycle or until it is determined participant must stop the drug. 4. Trilaciclib: d1, d2, d8 each cycle or until it is determined participant must stop the drug. Tislelizumab maintenance therapy:after chemoimmunotherapy, q3W until it is determined participant must stop the drug, or 2 years of treatment is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily participate in this study, able to provide written informed consent and can understand and agree to comply with the requirements of the study and schedule of assessments.
- Participants diagnosed histologically or cytologically with locally advanced or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter, bladder, or urethra. Eligible subjects for inclusion are those with a mixed histologic type, as assessed by the investigator, with urothelial component >50% and plasmacytoid subtype <10%. Patients with histologically confirmed and radiologically assessed locally advanced or metastatic urothelial carcinoma of the urinary tract.
- Participants judged by the investigator to be tolerant of platinum-based therapy. Participants intolerant to platinum chemotherapy must meet at least one of the following criteria: ECOG performance status >1 or Karnofsky performance status 60% to 70%; creatinine clearance less than 60 ml/min; hearing loss ≥ Grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5; peripheral neuropathy ≥ Grade 2 according to NCI-CTCAE version 5; New York Heart Association Class III or IV heart failure.
- Must provide surgical or biopsy tumor tissue samples, and concurrent submission of relevant pathology reports is required. Participants are able to submit fresh surgical tissue or submit pathology slides for examination.
- ECOG Performance Status 0 or 1
Key exclusion criteria (21 listed)
- Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. For patients with previously treated brain metastases, enrollment is not allowed if there has been CNS disease stability for at least 4 weeks before the first dose of study treatment and discontinuation of corticosteroid therapy for brain metastases for at least 2 weeks before the start of study treatment.
- Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, or other agents specifically targeting T-cell co-stimulation or checkpoint pathways.
- Receipt of other approved systemic anticancer therapy or systemic immunomodulatory agents (including but not limited to interferons, interleukins, and tumor necrosis factor) within 28 days before enrollment.
- Prior radiotherapy for bladder cancer.
- Prior systemic treatment for tumors, except:
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 |
|---|---|---|
| Tislelizumab, Cisplatin, Gemcitabine and TrilaciclibChemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle 4. Trilaciclib: 240mg/m2, d1, d2, d8 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W. | Drug | Gemcitabine, Cisplatin plus Trilaciclib |
| Tislelizumab, Cisplatin, GemcitabineChemoimmunotherapy: 1. Tislelizumab: 200mg, 1x time at d1 each cycle 2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle 3. Cisplatin: 70 mg/m2, in d2 each cycle Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W. | Drug | Gemcitabine plus Cisplatin |
Primary outcome
Percentage of Participants With Progression-Free Survival(PFS)
Time frame: 24 months
Progression free survival was determined from start date of treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at the date of last disease evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Percentage of Participants With Incidence of Grade 3/4 Neutropenia
Time frame: Within 28 days of initial dosing
The proportion of participant with neutrophils with values < 1*10^9/L during treatment.
6 secondary outcomes
Rate of ORR
Time frame: 60 months
overall survival (OS)
Time frame: 60 months
Safety and AE
Time frame: 60 months
Disease Control Rate(DCR)
Time frame: 60 months
During Of Response(DOR)
Time frame: 60 months
Biomarker Endpoint Analyses
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
Tianxin Lin, Ph.D study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib and Tislelizumab, Cisplatin, Gemcitabine in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 8 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 10 inclusion and 21 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wenlong Zhong, Ph.D (020-81338949, zhongwlong3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Progression-Free Survival(PFS) (time frame: 24 months). The study lists 2 primary outcomes in all. 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 21 Feb 2025.