Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of TherapyPhase 2NCT04603040
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
A Phase 2 study testing Toripalimab in people with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy, run by Shanghai Junshi Bioscience Co., Ltd. at 39 sites in China.
Trial summary
This is a single-arm, multicenter, phase 2 study to assess the efficacy and safety of Toripalimab Injection (JS001) in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 39 sitesChina
- Study dates
- 28 Sep 2020to 27 Mar 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- With pathologically diagnosed squamous cell carcinoma or sarcoma or undifferentiated carcinoma of the stomach or gastroesophageal junction;
- Patients with necrotic lesions, judged by the investigator to have a risk of massive hemorrhage;
- Symptomatic spinal cord compression, or untreated patients expected to have symptoms of spinal cord compression; or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease is clinically stable for ≥4 weeks before the first study drug administration; 1)Patients with asymptomatic spinal cord compression indicated by imaging, which is assessed as stable by specialists, unless treatment for spinal cord compression is not required temporarily;
- Poorly controlled pleural effusion, pericardial effusion or ascites requiring regular drainage;
- Accompanied by severe peritoneal metastasis, mainly manifested as: clinically significant intestinal obstruction; moderate to large amount of ascites; barium enema revealed small intestinal stenosis;
- Poorly controlled tumor-related pain; 1)For patients requiring analgesics, treatment must be on a stable dose prior to study participation; 2)Symptomatic lesions suitable for palliative radiotherapy (e.g., bone metastasis or metastasis resulting in nerve injury) should be treated before enrollment; 3)Prior to enrollment, local treatment of asymptomatic metastatic lesions that may cause functional deficit or intractable pain due to further growth (e.g., current epidural metastases not associated with spinal cord compression) should be considered if appropriate;
Show all 28Show fewer
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) assessment during screening and previous imaging assessment; 1)Patients who have previously received treatment for CNS metastases, shown to be stable for ≥4 weeks by imaging examination during the screening period, and stopped systemic hormone therapy (prednisone or other hormones with equal efficacy at a dose > 10 mg/day) for ≥4 weeks before the first study drug administration can participate in the study;
- Patients with a history of carcinomatous meningitis;
- Patients with a weight loss of more than 10% within 2 months before signing the informed consent form;
- Exclusion criteria for concurrent other diseases or concomitant conditions:
- Patients with other malignant tumors except for gastric cancer (except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer with radical treatment, ductal carcinoma in situ with radical treatment) within 5 years before the first study drug administration;
- Within 28 days prior to the first study drug administration, there are other major surgeries except for the diagnosis of gastric cancer, or major surgeries are expected to be performed during the study, unless assessed by researchers and specialists that they have fully recovered from the complications of major surgery;
- Clinically significant underlying medical conditions (e.g., dyspnea, pneumonia, pancreatitis, poorly controlled diabetes, active or poorly controlled infection, drug or alcohol abuse, or psychiatric disorders) that, in the opinion of the investigator, can affect study drug administration and protocol compliance;
- Presence of severe neurological or psychiatric disorders, including dementia and epileptic seizures;
- Have NCI-CTCAE ≥grade 2 peripheral neuropathy;
- Pregnant or lactating female patients;
- Patients with major cardiovascular diseases, such as heart disease of New York Heart Association (NYHA) functional class II or above (see Section 11.5 Appendix 5), myocardial infarction within 3 months before the first study drug administration, poorly controlled arrhythmia or unstable angina;
- 1)Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be treated with an optimized stable medical regimen at the discretion of the treating physician, with consultation with a cardiologist, as appropriate;
- 17. Previous history of hypersensitivity to other monoclonal antibodies or any component of Toripalimab Injection (JS001); 18. Previous treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor; 19. Participated in or planned to participate in other intervention studies within 4 weeks before the first study drug administration.
- 20. Treatment with systemic immunostimulatory drugs (including but not limited to interferon or IL-2) within 2 weeks or 5 half-lives of the drug (whichever is longer) before the first study drug administration; 21. Received systemic corticosteroids (> 10 mg/day prednisone equivalent drug) or other systemic immunosuppressive agents (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor drugs [anti-TNF]) within 2 weeks before the first study drug administration ;
- Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted;
- Patients receiving acute low-dose systemic immunosuppressive agents (e.g., a single dose of dexamethasone for nausea) can be enrolled after discussion with and approval by the medical monitor;
- Patients who need baseline and follow-up MRI/CT tumor assessment can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media.
- Inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted;
- 22. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Section 11.7, Appendix 7 for a more comprehensive list of autoimmune diseases);
- Patients with autoimmune-related hypothyroidism on stable doses of thyroid hormone replacement are eligible for this study;
- Patients with type 1 diabetes controlled on a stable insulin regimen are eligible for this study; 23. Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation; 24. Any live vaccine (e.g., vaccines against infectious diseases, such as influenza vaccine, varicella vaccine, etc.) within 4 weeks (28 days) before the first study drug administration; 25. Active infection, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);
- 1)Patients who are positive for hepatitis B surface antigen (HBsAg+) and/or hepatitis B core antibody (HBcAb+) are required to undergo hepatitis B virus deoxyribonucleic acid (HBV DNA) test. If HBV DNA copy number is ˂1000 cps/mL, or less than the lower limit of detectable value at the study site, the patients can participate in this study; 2)Patients who are positive for hepatitis C antibody (HCV Ab+) are required to have an HCV RNA test and are eligible for this study only if they are negative for HCV RNA (defined as below the lower limit of detectable value at the study site); 26. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
China39 sites
Affiliated Hospital of Hebei University
Baoding
Peking University International Hospital
Beijing
The First Hospital of Jilin University
Ch’ang-ch’un
Sichuan Cancer Hospital
Chengdu
Fujian Provincial Cancer Hospital
Fuzhou
Union Hospital affiliated to Fujian Medical University
Fuzhou
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou
Guangdong Provincial People's Hospital
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
The sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Zhejiang University School of Medicine, Sir Run Run Shaw Hospital
Hangzhou
Affiliated Tumor Hospital of Harbin Medical University
Harbin
Anhui Provincial Hospital
Hefei
Second Affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of Bengbu Medical College
Hefei
Henan Cancer Hospital
Henan
The First Affiliated Hospital of Nanhua University
Hengyang
Shandong Cancer Hospital
Jinan
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang
Jiangxi Provincial Cancer Hospital
Nanchang
The First Affiliated Hospital of Nanchang University Junhe Li
Nanchang
Jiangsu Cancer Hospital
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
Nantong Tumor Hospital
Nantong
Affiliated Hospital of Qingdao University
Qingdao
Shengjing Hospital of China Medical University
Shenyang
The First Affiliated Hospital of Soochow University
Suzhou
The Second Affiliated Hospital of Soochow University
Suzhou
Shanxi Cancer Hospital
Taiyuan
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Xiamen University
Xiamen
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang
Xuzhou Central Hospital
Xuzhou
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhengzhou Central Hospital
Zhengzhou
About this study
Official title: A Single-arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
This is a single-arm, multicenter, phase 2 study to assess the efficacy and safety of Toripalimab Injection (JS001) in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers.
Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks (q3w) until disease progression based on imaging according to RECIST 1.1 criteria judged by the investigator, or intolerable toxicity, or withdrawal of informed consent, or withdrawal of treatment judged by the investigator, or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months, or up to 2 years of treatment for JS001, whichever occurs first.
Read more
For the case that the patient shows disease progression on imaging according to RECIST 1.1, as long as the investigator judges that the patient can still benefit from continued medication, the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time. The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression.
Tumor assessments are performed at screening (as the baseline), every 6 weeks from the first dose in the first year, and every 9 weeks from the second year until radiologically documented progressive disease (PD), or second disease progression judged by the investigator (for patients with disease progression shown by first imaging, but who can continue treatment judged by the investigator), or withdrawal of informed consent by the patient, or loss to follow-up, or start of a new anti-tumor therapy, or the termination of the study. If a patient withdraws from the study for reasons other than disease progression (including due to the AE or because the treatment interval is beyond the window) and no disease progression occurs at the time of withdrawal, radiographic assessments should be continued until disease progression, death, or start of a new anti-tumor therapy. Patient medication management is based on the investigator's tumor assessment.
- Being tested
- Toripalimab
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Tuoyi
Experimental group:
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), In a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group:ToripalimabTreatment Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR assessed by IRC according to RECIST v1.1 assessment criteria. ORR is defined as the proportion of subjects with best response of complete response (CR) or partial response (PR).
Measured: Up to 12 months
Secondary outcomes (11)
Objective response rate (ORR)
ORR assessed by the investigator according to RECIST v1.1 assessment criteria. ORR is defined as the proportion of subjects with best response of CR or PR.
Measured: Up to 12 months
DoR
DoR is defined as the time from the first documented response until the first documented evidence of disease progression or death from any cause, whichever occurs first;
Measured: Up to 12 months
DCR
DCR is defined as the proportion of patients with best response of CR or PR or stable disease (SD);
Measured: Up to 12 months
PFS
PFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;
Measured: Up to 12 months
iORR
iORR is defined as the proportion of subjects with best response of CR or PR;
Measured: Up to 12 months
iDoR
iDoR is the time from the first documented response until the first documented evidence of disease progression or death from any cause, whichever occurs first;
Measured: Up to 12 months
iDCR
iDCR is the proportion of patients with best response of CR or PR or SD;
Measured: Up to 12 months
IPFS
IPFS is defined as the time from enrollment to the first documentation of disease progression or death from any cause, whichever occurs first;
Measured: Up to 12 months
Overall survival (OS)
Overall survival (OS), defined as the time from enrollment to death of the patient from any cause.
Measured: Up to 12 months
PFS rates at 6 and 12 months
It is defined as the proportion of patients alive without documented disease progression at 6 and 12 months after enrollment assessed by RECIST v1.1 criteria
Measured: Up to 12 months
OS rates at 9 months and 12 months
defined as the proportion of patients alive at 9 months and 12 months after enrollment.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start28 Sep 2020
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Why it stopped: Company R\&D Strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of TherapyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603040
- Sponsor's protocol ID
- JS001-033-II-GC
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2020
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
- ClinicalTrials.gov ID
- NCT04603040
- Acronym / sponsor ID
- JS001-033-II-GC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company R\&D Strategy
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 26 Oct 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 is a single-arm, multicenter, phase 2 study to assess the efficacy and safety of Toripalimab Injection (JS001) in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers.
Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks (q3w) until disease progression based on imaging according to RECIST 1.1 criteria judged by the investigator, or intolerable toxicity, or withdrawal of informed consent, or withdrawal of treatment judged by the investigator, or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months, or up to 2 years of treatment for JS001, whichever occurs first.
For the case that the patient shows disease progression on imaging according to RECIST 1.1, as long as the investigator judges that the patient can still benefit from continued medication, the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time. The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression.
Tumor assessments are performed at screening (as the baseline), every 6 weeks from the first dose in the first year, and every 9 weeks from the second year until radiologically documented progressive disease (PD), or second disease progression judged by the investigator (for patients with disease progression shown by first imaging, but who can continue treatment judged by the investigator), or withdrawal of informed consent by the patient, or loss to follow-up, or start of a new anti-tumor therapy, or the termination of the study. If a patient withdraws from the study for reasons other than disease progression (including due to the AE or because the treatment interval is beyond the window) and no disease progression occurs at the time of withdrawal, radiographic assessments should be continued until disease progression, death, or start of a new anti-tumor therapy. Patient medication management is based on the investigator's tumor assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: ToripalimabExperimental group:ToripalimabTreatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- With pathologically diagnosed squamous cell carcinoma or sarcoma or undifferentiated carcinoma of the stomach or gastroesophageal junction;
- Patients with necrotic lesions, judged by the investigator to have a risk of massive hemorrhage;
- Symptomatic spinal cord compression, or untreated patients expected to have symptoms of spinal cord compression; or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease is clinically stable for ≥4 weeks before the first study drug administration; 1)Patients with asymptomatic spinal cord compression indicated by imaging, which is assessed as stable by specialists, unless treatment for spinal cord compression is not required temporarily;
- Poorly controlled pleural effusion, pericardial effusion or ascites requiring regular drainage;
- Accompanied by severe peritoneal metastasis, mainly manifested as: clinically significant intestinal obstruction; moderate to large amount of ascites; barium enema revealed small intestinal stenosis;
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: TuoyiExperimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), In a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol. | Drug | Experimental group |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 12 months
ORR assessed by IRC according to RECIST v1.1 assessment criteria. ORR is defined as the proportion of subjects with best response of complete response (CR) or partial response (PR).
11 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 12 months
DoR
Time frame: Up to 12 months
DCR
Time frame: Up to 12 months
PFS
Time frame: Up to 12 months
iORR
Time frame: Up to 12 months
iDoR
Time frame: Up to 12 months
iDCR
Time frame: Up to 12 months
IPFS
Time frame: Up to 12 months
Overall survival (OS)
Time frame: Up to 12 months
PFS rates at 6 and 12 months
Time frame: Up to 12 months
OS rates at 9 months and 12 months
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Company R\&D Strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
39 sites 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 in people with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy, run by Shanghai Junshi Bioscience Co., Ltd. at 39 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 0 inclusion and 28 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: stopped early, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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 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 was stopped early (reason given: Company R\&D Strategy). Results are not available in the source record.
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?
Objective response rate (ORR) (time frame: Up to 12 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 28 Jul 2026.