Metastatic Gastric CancerPhase 2NCT04510064
Conversion Effects of PD-1 Antibody Camrelizumab Combined With Nab-POF Regimen Chemotherpy in Patients With Initially Unresectable Locally Advanced or Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma：FDZL-GC001 Trial
A Phase 2 study testing Camrelizumab plus mFLOT regimen and R0 surgery in people with Metastatic Gastric Cancer and Locally Advanced Gastric Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Cancer, Locally Advanced Gastric Adenocarcinoma, Gastric Cancer Adenocarcinoma Metastatic
- What is being tested?
- Camrelizumab plus mFLOT regimen and R0 surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2021to 31 Jul 2024
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Age ≥ 18 years at time of study entry, no gender limit.
- Participants must have histologically or cytologically confirmed adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction).
- At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
- CT or MRI showed unresectable locally advanced gastric cancer (imaging stage T4b and / or second station lymph node > 3cm or fusion mass) or limited metastatic gastric cancer with any of the following single site metastasis:
- Retro-peritoneal lymph node metastasis (RPLM) (e.g. para-aortic, intra-aorto-caval, para-pancreatic or mesenteric lymph nodes).
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- Single or bilateral Krukenberg tumors.
- No more than 5 liver metastases, and the maximum diameter of the lesions was less than 5 cm.
- Adrenal metastasis.
- Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the"Japanese Research Society for Gastric Cancer (JRSCGC)".
- No clinically visible peritoneal metastasis (such as CT imaging confirmation or ascites).
- No prior anti-tumor therapy.
- Performance status (PS) < 2 (ECOG scale).
- Life expectancy of at least 12 weeks.
- Adequate blood count, liver-enzymes, and renal function: hemoglobin≥90g/dL,absolute neutrophil count ≥ 1.5×109/L, platelets ≥100 x109/L; Total bilirubin < 1.5x upper normal limit (UNL), Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) <2.5 x ULN, if liver metastasis existed, SGOT,SGPT<2.5xULN. International normalized ratio (INR) ≤2.5 x ULN, Serum Creatinine ≤ 1 x institutional ULN or creatinine clearance (CrCl) >50ml/min (if using the Cockcroft-Gault formula ).
- Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.
Who cannot join
- A history of other malignancies within 3 years prior to enrollment, except for cervical carcinoma in situ or skin basal cell carcinoma that had been cured.
- Accompanied with brain or meningeal metastasis.
- Malignant pleural and peritoneal effusion.
- Accompanied by gastrointestinal obstruction, gastrointestinal bleeding (fecal occult blood +++ )or perforation.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has an active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or with high risk (such as receiving immunosuppressive therapy after organ transplantation), but in the past two years with vitiligo, psoriasis, alopecia or Graves' disease without systemic treatment, hypothyroidism with thyroid hormone replacement therapy only and type I diabetes only need insulin replacement therapy can be enrolled.
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- Suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease and radiation pneumonia.
- Participate in other clinical studies of drugs (subject to the use of trial drugs) within 4 weeks before the first administration, unless participating in observational (non intervention) clinical studies.
- Used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. no more than 10mg prednisone or equivalent dose of other glucocorticoids, or short-term (no more than 7 days) use of glucocorticoids to prevent or treat non autoimmune allergic diseases.
- Planned to receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period. Note: inactivated virus vaccine for seasonal influenza is allowed within 4 weeks before the first administration, however, live attenuated influenza vaccine is not allowed.
- Major surgery (craniotomy, thoracotomy or laparotomy) was performed within 4 weeks before the first dose of study treatment, or major surgery (not in this study) was expected to be performed during the study treatment.
- A history of HIV infection (i.e. HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or stem cell transplantation.
- Patients with active chronic hepatitis B or active hepatitis C, hepatitis B virus carriers. Stable hepatitis B after drug treatment (DNA titer not higher than 200iu/ml or copy number < 1000copies / ml) and cured patients with hepatitis C (HCV RNA test negative) can be included in the group.
- Active tuberculosis.
- Severe infection within 4 weeks before the first administration, or active infection within the first 2 weeks and requiring oral or intravenous antibiotic treatment.
- Symptomatic congestive heart failure (NYHA grade II-IV) or symptomatic or poorly controlled arrhythmias;
- Uncontrolled arterial hypertension (systolic blood pressure≥160mmhg or diastolic blood pressure≥100mmhg) even after standard treatment.
- Any arterial thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the treatment.
- A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered as "severe" thromboembolism)
- Have a clear history of neurological or mental disorders in the past, such as epilepsy, dementia, poor compliance, or patients with peripheral nervous system disorders.
- Alcohol addicts or have a history of drug use or drug abuse in the past 1 yea.
- Pregnant or lactating women, fertile women without adequate contraceptive measures
- Other acute or chronic diseases, mental disorders, or laboratory test value abnormalities that may result in increased risk associated with study participation or drug administration, or interference with the interpretation of the study results, and the patient, in the judgment of the investigator, is not eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University, Shanghai Cancer Center
Shanghai, Shanghai Municipality, 210000
About this study
This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.
Read the detailed description
This is an open, single center, prospective phase II clinical study to evaluate the efficacy and safety of domestic PD1 antibody (Camrelizumab for injection) combined with Nab-POF regimen in the treatment of unresectable locally advanced or limited metastatic gastric cancer. This study will be carried out in our center, about 40 patients will be enrolled.
Patients with unresectable locally advanced or limited metastatic gastric cancer who had not received any prior antitumor therapies were treated with domestic PD1 antibody (Caerelizumab for injection) commbined with mFLOT regimen, and human epidermal-growth-factor receptor 2 (HER-2) positive patients were treated with Herceptin. The efficacy of therapy was evaluated every 3 treatment cycles. After 6 cycles, surgical experts evaluated the resectability of the tumor, and the patients who were confirmed to be resectable received surgery within 3-6 weeks after immunochemotherapy. The patients with good postoperative recovery continued to receive the same immunochemotherapy in 3-6 weeks, and totally at most 12 cycles. Patients who were evaluated as progressive disease (PD) at any time withdrawn from the study as conversion failure.Patients who did not PD at 6 cycles of treatment but did not reach the criteria for R0 resection, continued to receive another 3 cycles of the prior chemotherapy. If resectable then, surgical treatment was performed, if still unresectable, the immunochemotherapy for transformation was evaluated as unsuccessful. The patients were treated according to the principle of palliative treatment until the disease progressed or intolerable toxicity. The efficacy and safety will be continuously monitored and evaluated throughout the study period (including a 30 day follow-up period). 40 cases were expected to be enrolled: 3-4 cases per month, completed in 1 year and finished in 2 years.
- Conditions
- Metastatic Gastric Cancer, Locally Advanced Gastric Adenocarcinoma, Gastric Cancer Adenocarcinoma Metastatic
- Being tested
- Camrelizumab plus mFLOT regimen, R0 surgery
- Keywords
- gastric cancer, gastroesophageal adenocarcnoma, conversion chemotherapy, PD-1antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab plus mFLOT regimenDrug
Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.
R0 surgeryProcedure or surgery
The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every two weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity. Receives: Drug: Camrelizumab plus mFLOT regimen; Procedure: R0 surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
margin-free-(R0) resection rate
R0 resection was defined as no tumor identified on microscopic examination of proximal, distal,or circumferential margins.
Measured: 6-9 weeks after immunochemotherapy
Secondary outcomes (6)
pathological complete response (pCR)
Measured: 6-9 weeks after immunochemotherapy and R0 surgery
overall response rate (ORR)
Measured: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 24 months
sugery complications
sugery complications
Measured: up to 2 months after the period of surgery
progression free survival (PFS)
randomisation to disease progression, relapse, or death; surgical morbidity and mortality
Measured: up to 24 months
overall survival (OS)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start6 Jan 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Sequential
- Model description
- Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen, and HER-2 positive patients were added Herceptin therapy. If primary tumor and metastatic lesions could be converted to R0 resection after 6-9 cycles of immunochemotherapy, then proceeded to surgery,otherwize treated according to the principles of palliative care. Patiens after surgery continued prior immunotherapy to 12 cycles or intolerable toxicity.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- weijian guo, professor, Principal investigator, Fudan university, Shanghai Cancer Certer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510064
- Sponsor's protocol ID
- FDZL-PFG
- Status last verified
- Mar 2025
- First submitted
- 10 Aug 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Effects of PD-1 Antibody Camrelizumab Combined With Nab-POF Regimen Chemotherpy in Patients With Initially Unresectable Locally Advanced or Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma：FDZL-GC001 Trial
- ClinicalTrials.gov ID
- NCT04510064
- Acronym / sponsor ID
- FDZL-PFG
- Conditions
- Metastatic Gastric Cancer, Locally Advanced Gastric Adenocarcinoma, Gastric Cancer Adenocarcinoma Metastatic
- Keywords
- gastric cancer, gastroesophageal adenocarcnoma, conversion chemotherapy, PD-1antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 12 Aug 2020 (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.
This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.
Detailed description
This is an open, single center, prospective phase II clinical study to evaluate the efficacy and safety of domestic PD1 antibody (Camrelizumab for injection) combined with Nab-POF regimen in the treatment of unresectable locally advanced or limited metastatic gastric cancer. This study will be carried out in our center, about 40 patients will be enrolled.
Patients with unresectable locally advanced or limited metastatic gastric cancer who had not received any prior antitumor therapies were treated with domestic PD1 antibody (Caerelizumab for injection) commbined with mFLOT regimen, and human epidermal-growth-factor receptor 2 (HER-2) positive patients were treated with Herceptin. The efficacy of therapy was evaluated every 3 treatment cycles. After 6 cycles, surgical experts evaluated the resectability of the tumor, and the patients who were confirmed to be resectable received surgery within 3-6 weeks after immunochemotherapy. The patients with good postoperative recovery continued to receive the same immunochemotherapy in 3-6 weeks, and totally at most 12 cycles. Patients who were evaluated as progressive disease (PD) at any time withdrawn from the study as conversion failure.Patients who did not PD at 6 cycles of treatment but did not reach the criteria for R0 resection, continued to receive another 3 cycles of the prior chemotherapy. If resectable then, surgical treatment was performed, if still unresectable, the immunochemotherapy for transformation was evaluated as unsuccessful. The patients were treated according to the principle of palliative treatment until the disease progressed or intolerable toxicity. The efficacy and safety will be continuously monitored and evaluated throughout the study period (including a 30 day follow-up period). 40 cases were expected to be enrolled: 3-4 cases per month, completed in 1 year and finished in 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen, and HER-2 positive patients were added Herceptin therapy. If primary tumor and metastatic lesions could be converted to R0 resection after 6-9 cycles of immunochemotherapy, then proceeded to surgery,otherwize treated according to the principles of palliative care. Patiens after surgery continued prior immunotherapy to 12 cycles or intolerable toxicity.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Camrelizumab plus mFLOT regimen, Procedure: R0 surgeryPatients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every two weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written informed consent obtained.
- Age ≥ 18 years at time of study entry, no gender limit.
- Participants must have histologically or cytologically confirmed adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction).
- At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
- CT or MRI showed unresectable locally advanced gastric cancer (imaging stage T4b and / or second station lymph node > 3cm or fusion mass) or limited metastatic gastric cancer with any of the following single site metastasis:
Key exclusion criteria (23 listed)
- A history of other malignancies within 3 years prior to enrollment, except for cervical carcinoma in situ or skin basal cell carcinoma that had been cured.
- Accompanied with brain or meningeal metastasis.
- Malignant pleural and peritoneal effusion.
- Accompanied by gastrointestinal obstruction, gastrointestinal bleeding (fecal occult blood +++ )or perforation.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
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 |
|---|---|---|
| Camrelizumab plus mFLOT regimenPatients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed. | Drug | Treatment group |
| R0 surgeryThe efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity. | Procedure or surgery | Treatment group |
Primary outcome
margin-free-(R0) resection rate
Time frame: 6-9 weeks after immunochemotherapy
R0 resection was defined as no tumor identified on microscopic examination of proximal, distal,or circumferential margins.
6 secondary outcomes
pathological complete response (pCR)
Time frame: 6-9 weeks after immunochemotherapy and R0 surgery
overall response rate (ORR)
Time frame: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 24 months
sugery complications
Time frame: up to 2 months after the period of surgery
progression free survival (PFS)
Time frame: up to 24 months
overall survival (OS)
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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. This study is not recruiting at the moment.
weijian guo, professor principal investigator
Fudan university, Shanghai Cancer Certer
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 Camrelizumab plus mFLOT regimen and R0 surgery in people with Metastatic Gastric Cancer and Locally Advanced Gastric Adenocarcinoma, run by Fudan 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 17 inclusion and 23 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: finished, as of the sponsor's last update on 12 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
margin-free-(R0) resection rate (time frame: 6-9 weeks after immunochemotherapy). 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 12 Mar 2025.