Muscle-Invasive Bladder CarcinomaPhase 2BCIRT-01NCT05975307
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
A Phase 2 study testing Toripalimab, Gemcitabine and Cisplatin in people with Muscle-Invasive Bladder Carcinoma and Programmed Cell Death Protein 1 Inhibitor, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of neoadjuvant chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy
- What is being tested?
- Toripalimab, Gemcitabine and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2029
- 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
- Pathologically diagnosed bladder malignant tumor via biopsy
- Urothelial carcinoma as the primary histological component
- Pretreatment clinical TNM stage as T2-4aN0-2M0 (UICC TNM staging classification, version 8)
- Age between 18 and 75 years old
- Karnofsky performance score ≥ 70
- Creatinine clearance rate ≥ 30 ml/min
Who cannot join
- Simultaneous tumors of the urethra or upper urinary tract
- Existence of small cell cancer component
- Uncontrolled tuberculosis, viral hepatitis or AIDS
- Autoimmune or mental diseases
- Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy
- Prior history of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
Show all 11Show fewer
- Prior history of pelvic radiotherapy or chemotherapy
- Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.)
- Pregnant or lactating women
- Treatment with glucocorticoid or immunosuppressive drugs within 1 month
- Other situations for which the investigators consider a patient inappropriate to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Phase II Clinical Trial to Treat Muscle-invasive Bladder Cancer With Neoadjuvant Chemotherapy Plus Anti-PD-1 Therapy Followed by Radiotherapy Plus Concurrent Anti-PD-1 Therapy
The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of neoadjuvant chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is effective in treating muscle-invasive bladder cancer (MIBC), when combined with chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation. Participants will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.
Read the detailed description
Bladder cancer is the second most common malignancies over the world. At initial diagnosis, the cases with muscle-invasive bladder cancer (MIBC) accounts nearly 20% of all bladder cancer patients. And 40% of non-muscle-invasive bladder cancer could develop to MIBC. Currently, radical cystectomy (RC) is the golden standard to manage MIBC. Yet, it brings severe surgical injuries and post-surgical complications which impair life quality of the patients. Recently, bladder-preserving treatment based gradually becomes the second choice for MIBC. It consists of maximal transurethral resection of bladder tumor (TURBT) and chemoradiation. A series of clinical trials and meta-analyses supported that the bladder-preserving treatment has a similar therapeutic effect compared with RC. But it is noteworthy that this treatment mode does not really avoid surgery. TURBT could also cause complications, such as haemorrhage, infection, perforation, and even tumor dissemination. Moreover, the incidence of serious toxicities brought by concurrent chemoradiation is as high as 36%. In actual clinical work, it is hard for more than half patients to complete chemoradiation of standard intensity. Additionally, many patients are unsuitable for bladder preservation, including those with T stage > T2, diameter > 5 cm, hydronephrosis and positive lymph nodes. Hence, it calls for improvement of current bladder preservation mode, to make more MIBC patients receive radical treatment which brings better therapeutic experience and life quality.
Many lab studies indicated that formation and progression of bladder cancer is a process of mutation accumulation. It provides biological fundamentals for immune checkpoint inhibitors, such as anti-programmed cell death protein 1 (anti-PD-1) antibodies. Based on available clinical studies, anti-PD-1 antibodies exhibits ideal therapeutic effects in bladder cancer of different stages and has an incidence of toxicities as low as 13%. Its toxicities mainly include arthralgia and hyponatremia, which are well tolerated. Currently, there are more than 10 clinical trials trying anti-PD-1 antibodies for bladder preservation. However, the treatment modes in most of them still contain TURBT. This phase 2 trial intended to evaluate the therapeutic and adverse effects of a non-surgical bladder-preserving treatment mode consisting of anti-PD-1 antibodies and chemoradiation, in a small patient cohort with MIBC. The results might provide an effective, non-invasive and low-toxic choice which improves patient experience and realizes bladder preservation.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy
- Being tested
- Toripalimab, Gemcitabine, Cisplatin, Carboplatin, Intensity-modulated radiation therapy
- Keywords
- Bladder Cancer, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy, Chemotherapy, Bladder Preservation
- 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.
ToripalimabDrug
Also called JS001
The patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
Toripalimab: 240 mg on Day 1, every 3 weeks, totally 3 and 2 cycles in the neoadjuvant and concurrent phases, respectively.
GemcitabineDrug
The patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
Gemcitabine: 1 g/m2 on Days 1 and 8, repeated every 3 weeks, totally 3 cycles.
CisplatinDrug
The patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
Cisplatin: Used when creatinine clearance rate ≥ 40 ml/min, 37.5 mg/m2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.
CarboplatinDrug
The patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
Cisplatin: Used when creatinine clearance rate < 40 ml/min, area under curve = 2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles.
Intensity-modulated radiation therapyRadiation
The patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab.
Radiotherapy: performed by using the technique of intensity-modulated radiation therapy, with a total dose of 65 and 45 Gy for the gross tumor and lymphatic drainage regions.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab plus chemoradiation | Experimental | This study has only single arm in which the patients will receive neoadjuvant chemotherapy plus anti-PD-1 therapy (toripalimab), followed by radiotherapy plus concurrent anti-PD-1 therapy Receives: Drug: Toripalimab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Radiation: Intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complete response (cCR) rate
The percentage of the cases attaining cCR of primary tumor and regional lymph nodes (confirmed by radiologic examinations, such as thoraco-bdominal computed tomography, pelvic magnetic resonance imaging, and multipoint biopsy under cystoscopy)
Measured: When the eligible patients complete the treatment and followed-up for half a year
Secondary outcomes (7)
Overall survival (OS)
The percentage of the cases surviving over a given time period
Measured: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Bladder-intact event-free survival (BI-EFS)
The percentage of the cases surviving with intact bladder and without muscle-invasive recurrence, regional lymph node recurrence or distant metastasis, over a given time period
Measured: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Disease-free survival (DFS)
The percentage of the cases surviving without locoregional recurrence or distant metastasis over a given time period
Measured: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Local recurrence (LR) rate
The percentage of the cases with locoregional recurrence over a given time period
Measured: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Incidence of grade 3/4 (G3/4) toxicities
The percentage of the cases with any G3/4 toxicity during and after treatment
Measured: Once a week during treatment, and once per 3 months after treatment, until the last follow-up (2 years after treatment)
Bladder function
The quantitative score of bladder function at a given time point, based on the Quality of Life 30-item Questionnaire, Bladder Module (QLQ-BLM30) from the EORTC
Measured: Once per 3 months after treatment, until the last follow-up (2 years after treatment)
Objective response rate (ORR)
The percentage of the cases attaining clinical complete or partial response of primary tumor and regional lymph nodes (confirmed by radiography and cystoscopy)
Measured: A week before radiotherapy, and once per 3 months after treatment, until the last follow-up (2 years after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder 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
- This phase 2 trial is an open-label, single-arm, non-comparative trial, in which all eligible patients will receive neoadjuvant chemotherapy plus toripalimab, followed by radiotherapy plus concurrent toripalimab.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-hong Gao, Sun Yat-sen University
- Investigators
- Yuanhong Gao, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975307
- Sponsor's protocol ID
- 2023-FXY-068
- Acronym
- BCIRT-01
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2023
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Clinical Trial to Treat Muscle-invasive Bladder Cancer With Neoadjuvant Chemotherapy Plus Anti-PD-1 Therapy Followed by Radiotherapy Plus Concurrent Anti-PD-1 Therapy
- ClinicalTrials.gov ID
- NCT05975307
- Acronym / sponsor ID
- BCIRT-01 / 2023-FXY-068
- Conditions
- Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy
- Keywords
- Bladder Cancer, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy, Chemotherapy, Bladder Preservation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Aug 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 goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of neoadjuvant chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is effective in treating muscle-invasive bladder cancer (MIBC), when combined with chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation. Participants will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.
Detailed description
Bladder cancer is the second most common malignancies over the world. At initial diagnosis, the cases with muscle-invasive bladder cancer (MIBC) accounts nearly 20% of all bladder cancer patients. And 40% of non-muscle-invasive bladder cancer could develop to MIBC. Currently, radical cystectomy (RC) is the golden standard to manage MIBC. Yet, it brings severe surgical injuries and post-surgical complications which impair life quality of the patients. Recently, bladder-preserving treatment based gradually becomes the second choice for MIBC. It consists of maximal transurethral resection of bladder tumor (TURBT) and chemoradiation. A series of clinical trials and meta-analyses supported that the bladder-preserving treatment has a similar therapeutic effect compared with RC. But it is noteworthy that this treatment mode does not really avoid surgery. TURBT could also cause complications, such as haemorrhage, infection, perforation, and even tumor dissemination. Moreover, the incidence of serious toxicities brought by concurrent chemoradiation is as high as 36%. In actual clinical work, it is hard for more than half patients to complete chemoradiation of standard intensity. Additionally, many patients are unsuitable for bladder preservation, including those with T stage > T2, diameter > 5 cm, hydronephrosis and positive lymph nodes. Hence, it calls for improvement of current bladder preservation mode, to make more MIBC patients receive radical treatment which brings better therapeutic experience and life quality.
Many lab studies indicated that formation and progression of bladder cancer is a process of mutation accumulation. It provides biological fundamentals for immune checkpoint inhibitors, such as anti-programmed cell death protein 1 (anti-PD-1) antibodies. Based on available clinical studies, anti-PD-1 antibodies exhibits ideal therapeutic effects in bladder cancer of different stages and has an incidence of toxicities as low as 13%. Its toxicities mainly include arthralgia and hyponatremia, which are well tolerated. Currently, there are more than 10 clinical trials trying anti-PD-1 antibodies for bladder preservation. However, the treatment modes in most of them still contain TURBT. This phase 2 trial intended to evaluate the therapeutic and adverse effects of a non-surgical bladder-preserving treatment mode consisting of anti-PD-1 antibodies and chemoradiation, in a small patient cohort with MIBC. The results might provide an effective, non-invasive and low-toxic choice which improves patient experience and realizes bladder preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This phase 2 trial is an open-label, single-arm, non-comparative trial, in which all eligible patients will receive neoadjuvant chemotherapy plus toripalimab, followed by radiotherapy plus concurrent toripalimab.
| Arm | Type | Receives |
|---|---|---|
| Toripalimab plus chemoradiation | Experimental | Drug: Toripalimab, Drug: Gemcitabine, Drug: Cisplatin, Drug: Carboplatin, Radiation: Intensity-modulated radiation therapyThis study has only single arm in which the patients will receive neoadjuvant chemotherapy plus anti-PD-1 therapy (toripalimab), followed by radiotherapy plus concurrent anti-PD-1 therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically diagnosed bladder malignant tumor via biopsy
- Urothelial carcinoma as the primary histological component
- Pretreatment clinical TNM stage as T2-4aN0-2M0 (UICC TNM staging classification, version 8)
- Age between 18 and 75 years old
- Karnofsky performance score ≥ 70
Key exclusion criteria (11 listed)
- Simultaneous tumors of the urethra or upper urinary tract
- Existence of small cell cancer component
- Uncontrolled tuberculosis, viral hepatitis or AIDS
- Autoimmune or mental diseases
- Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy
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 |
|---|---|---|
| ToripalimabAlso: JS001The patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab. Toripalimab: 240 mg on Day 1, every 3 weeks, totally 3 and 2 cycles in the neoadjuvant and concurrent phases, respectively. | Drug | Toripalimab plus chemoradiation |
| GemcitabineThe patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab. Gemcitabine: 1 g/m2 on Days 1 and 8, repeated every 3 weeks, totally 3 cycles. | Drug | Toripalimab plus chemoradiation |
| CisplatinThe patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab. Cisplatin: Used when creatinine clearance rate ≥ 40 ml/min, 37.5 mg/m2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles. | Drug | Toripalimab plus chemoradiation |
| CarboplatinThe patients in this arm will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab. Cisplatin: Used when creatinine clearance rate < 40 ml/min, area under curve = 2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles. | Drug | Toripalimab plus chemoradiation |
| Intensity-modulated radiation therapyThe patients in this arm will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy, plus 2 cycles of concurrent toripalimab. Radiotherapy: performed by using the technique of intensity-modulated radiation therapy, with a total dose of 65 and 45 Gy for the gross tumor and lymphatic drainage regions. | Radiation | Toripalimab plus chemoradiation |
Primary outcome
Clinical complete response (cCR) rate
Time frame: When the eligible patients complete the treatment and followed-up for half a year
The percentage of the cases attaining cCR of primary tumor and regional lymph nodes (confirmed by radiologic examinations, such as thoraco-bdominal computed tomography, pelvic magnetic resonance imaging, and multipoint biopsy under cystoscopy)
7 secondary outcomes
Overall survival (OS)
Time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Bladder-intact event-free survival (BI-EFS)
Time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Disease-free survival (DFS)
Time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Local recurrence (LR) rate
Time frame: When the eligible patients complete the treatment and followed-up for 1 and 2 years
Incidence of grade 3/4 (G3/4) toxicities
Time frame: Once a week during treatment, and once per 3 months after treatment, until the last follow-up (2 years after treatment)
Bladder function
Time frame: Once per 3 months after treatment, until the last follow-up (2 years after treatment)
Objective response rate (ORR)
Time frame: A week before radiotherapy, and once per 3 months after treatment, until the last follow-up (2 years after treatment)
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 3 Nov 2026.
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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.
Yuanhong Gao, MD principal investigator
Sun Yat-sen 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 Toripalimab, Gemcitabine and Cisplatin in people with Muscle-Invasive Bladder Carcinoma and Programmed Cell Death Protein 1 Inhibitor, run by Sun Yat-sen 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response (cCR) rate (time frame: When the eligible patients complete the treatment and followed-up for half a year). 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 3 Nov 2026.