Gastric or Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT07727993
Neoadjuvant Propranolol Plus SOX and Toripalimab for Locally Advanced Gastric/GEJ Adenocarcinoma
A Phase 1/2 study testing propranolol, Toripalimab and Oxaliplatin in people with Gastric or Gastroesophageal Junction Adenocarcinoma and Propranolol, run by Ting Liu.
Trial summary
This is a single-center, prospective, open-label, single-arm, phase Ib/II study evaluating the safety and efficacy of neoadjuvant propranolol combined with SOX chemotherapy and toripalimab in patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma, Propranolol, SOX Chemotherapy
- What is being tested?
- propranolol, Toripalimab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- Voluntary participation in the study, with written informed consent, and willingness and ability to comply with the study treatment and follow-up requirements.
- Male or female participants aged 18 to 75 years.
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma.Resectable locally advanced disease as determined by imaging assessment or a multidisciplinary team according to the eighth edition of the American Joint Committee on Cancer staging system, generally defined as cT3-4a with any N category, or any T category with node-positive disease, corresponding to stage II-III disease, without distant metastasis.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Acceptable cardiopulmonary function, including all of the following:
- (1)No clinically significant abnormality on electrocardiography; (2)Resting heart rate of at least 60 beats per minute; (3)Systolic blood pressure of at least 90 mmHg; (4)No progressive or decompensated cardiopulmonary disease; (5)Left ventricular ejection fraction of at least 50%. 6.Adequate organ function during screening, defined as follows:
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- Absolute neutrophil count of at least 1.5 × 10⁹/L;
- Platelet count of at least 75 × 10⁹/L;
- Hemoglobin level of at least 90 g/L;
- Total bilirubin no greater than 1.5 times the upper limit of normal;
- Aspartate aminotransferase and alanine aminotransferase no greater than 2.5 times the upper limit of normal;
- Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance of at least 50 mL/min;
- International normalized ratio no greater than 1.5 times the upper limit of normal, unless the participant is receiving stable anticoagulation and is considered eligible by the investigator.
- 7.Female participants of childbearing potential must have a negative pregnancy test during screening. Male and female participants of reproductive potential must agree to use effective contraception during the study and for at least 6 months after the last dose of study treatment.
Who cannot join
- Distant metastatic disease confirmed by imaging or diagnostic laparoscopy, including but not limited to peritoneal, hepatic, or bone metastases, or positive peritoneal cytology.
- Previous systemic anticancer treatment for the current malignancy, including chemotherapy, immunotherapy, or targeted therapy, or previous radiotherapy. Diagnostic endoscopy and biopsy are permitted.
- Grade 2 or higher peripheral neuropathy at baseline.
- A second primary malignancy requiring systemic treatment within the previous 3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, low-risk thyroid cancer, or other malignancies considered cured.
- Inability to tolerate curative-intent surgery or study treatment, as determined by the investigator.
- Active autoimmune disease, or a clinically significant history of autoimmune disease requiring systemic immunosuppressive treatment within the previous 2 years. Participants with type 1 diabetes mellitus, stable thyroid disease requiring replacement therapy, vitiligo, or grade 2 or lower psoriasis not requiring systemic treatment may be eligible.
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- Use of systemic corticosteroids at a prednisone-equivalent dose of at least 10 mg/day, or other systemic immunosuppressive agents, within 14 days before the planned initiation of immunotherapy. Physiologic replacement therapy, inhaled or topical corticosteroids, and short-term prophylactic treatment related to surgery are permitted.
- Active infection, including but not limited to active tuberculosis, uncontrolled hepatitis B virus or hepatitis C virus infection, human immunodeficiency virus infection, or another serious infection requiring intravenous antibiotic treatment.
- Any contraindication to propranolol, including:
- (1)Bronchial asthma or a risk of bronchospasm; (2)Diabetic ketoacidosis or metabolic acidosis; (3)Severe or symptomatic bradycardia; (4)Second- or third-degree atrioventricular block, sinoatrial block, or sick sinus syndrome; (5)Cardiogenic shock; (6)Right-sided heart failure caused by pulmonary hypertension; (7)Congestive heart failure; (8)Clinically significant hypotension; (9)Prolonged fasting; (10)Severe peripheral circulatory failure; (11)Untreated pheochromocytoma; (12)Variant angina; (13)Concomitant treatment with rizatriptan benzoate. 10.Moderate or severe chronic obstructive pulmonary disease with a recent acute exacerbation.
- 11.Active upper gastrointestinal bleeding at baseline, melena or hematemesis within the previous 4 weeks, bleeding requiring blood transfusion or endoscopic hemostasis, uncontrolled peptic ulcer disease, or a high risk of recent bleeding as determined by the investigator.
- 12.Requirement for continuous full-dose anticoagulation, dual antiplatelet therapy that cannot be interrupted, or a bleeding disorder that cannot be adequately managed during the perioperative period.
- 13.Known hypersensitivity to propranolol, oxaliplatin, S-1 or fluoropyrimidines, toripalimab, or any of their excipients, or a history of a severe adverse reaction to any of these agents.
- 14.Concomitant use of medications that cannot be discontinued or replaced and that may cause clinically significant interactions with propranolol, including verapamil, diltiazem, class I or class III antiarrhythmic agents, strong CYP2D6 or CYP1A2 inhibitors, or other medications considered by the investigator to pose a major drug-drug interaction risk.
- 15.Uncontrolled bleeding disorder, or major surgery or serious trauma within 4 weeks before enrollment, excluding the curative-intent surgery planned as part of this study.
- 16.Pregnancy or breastfeeding, or unwillingness to use the required contraceptive measures.
- 17.Any medical, psychiatric, social, or other condition that, in the investigator's judgment, may compromise participant safety, treatment compliance, or completion of the required follow-up, including severe psychiatric illness, substance abuse, or inability to attend scheduled visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-Label, Single-Arm, Phase Ib/II Study of Neoadjuvant Propranolol Plus SOX Chemotherapy and Toripalimab in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a single-center, prospective, open-label, single-arm, phase Ib/II study evaluating the safety and efficacy of neoadjuvant propranolol combined with SOX chemotherapy and toripalimab in patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 49 participants will be enrolled. Stage 1 includes an initial safety lead-in of 12 participants, followed by efficacy evaluation using a Simon two-stage design. Participants will receive propranolol, toripalimab, oxaliplatin, and S-1 during the neoadjuvant period, followed by curative-intent surgery.
The primary efficacy endpoint is pathological complete response. Secondary endpoints include safety and tolerability, major pathological response, R0 resection rate, event-free survival, recurrence-free survival, and overall survival. Exploratory analyses will assess changes in adrenergic stress markers, heart rate variability, peripheral immune parameters, β-adrenergic receptor signaling, and the tumor immune microenvironment.
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma, Propranolol, SOX Chemotherapy, Toripalimab
- Being tested
- propranolol, Toripalimab, Oxaliplatin, S-1
- Keywords
- gastric or gastroesophageal junction adenocarcinoma, propranolol, OX chemotherapy, toripalimab, neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Propranolol will be administered orally at 10 mg twice daily beginning on Day 1 of the first neoadjuvant treatment cycle. The dose may be reduced to 5 mg twice daily, temporarily interrupted, or discontinued according to tolerability and predefined safety criteria, including heart rate, blood pressure, respiratory symptoms, and cardiac conduction abnormalities. Propranolol may be continued during postoperative treatment until completion of adjuvant therapy or the occurrence of unacceptable toxicity.
ToripalimabDrug
Toripalimab will be administered intravenously at a fixed dose of 240 mg on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. After surgery, 3 additional cycles are recommended, followed by toripalimab maintenance as clinically appropriate for a total immunotherapy duration of up to 1 year from the first dose.
OxaliplatinDrug
Oxaliplatin will be administered intravenously at 130 mg/m² on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. Three additional postoperative cycles are recommended according to postoperative recovery, tolerability, and the investigator's assessment. Dose modification, interruption, or discontinuation will be permitted for treatment-related toxicity.
S-1Drug
S-1 will be administered orally twice daily on Days 1-14 of each 21-day cycle, followed by a 7-day rest period. The total daily dose will be determined according to body surface area: 80 mg/day for body surface area below 1.25 m², 100 mg/day for body surface area of 1.25-1.49 m², and 120 mg/day for body surface area of 1.50 m² or greater. Participants will receive 3 neoadjuvant cycles, with 3 additional postoperative cycles recommended according to tolerability and postoperative recovery.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Plus SOX and Toripalimab | Experimental | Not described Receives: Drug: propranolol; Drug: Toripalimab; Drug: Oxaliplatin; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
The proportion of participants with no residual viable tumor cells in the resected primary tumor and all dissected regional lymph nodes following neoadjuvant treatment, corresponding to Becker grade 1a. Participants who do not undergo surgery or do not have an assessable pathological result will be classified as non-pCR in the intention-to-treat analysis.
Measured: At curative-intent surgery following completion of 3 neoadjuvant treatment cycles, approximately 13 to 15 weeks after treatment initiation.
Secondary outcomes (8)
Dose-Limiting Toxicity (DLT) Rate During the Safety Lead-in
The proportion of participants in the initial safety lead-in cohort who experience a dose-limiting toxicity related to study treatment. DLTs include predefined severe hematologic, nonhematologic, immune-related, cardiovascular, respiratory, or gastrointestinal toxicities; treatment-related death; or treatment-related toxicity resulting in a treatment delay of more than 21 days or inability to undergo planned surgery.
Measured: From the first dose of study treatment through 30 days after surgery
Incidence of Treatment-Related Adverse Events
The proportion of participants who experience treatment-related adverse events, serious adverse events, or immune-related adverse events. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From the first dose of study treatment through at least 30 days after the last dose, or until treatment-related adverse events have resolved or stabilized
Postoperative Complication Rate
The proportion of participants who experience postoperative complications following curative-intent surgery. Complications will be classified according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Major Pathological Response (MPR) Rate
The proportion of participants with 10% or less residual viable tumor cells in the resected primary tumor following neoadjuvant treatment. Participants who do not undergo surgery or do not have an assessable pathological result will be classified as non-MPR in the intention-to-treat analysis.
Measured: At curative-intent surgery following completion of neoadjuvant treatment, approximately 13 to 15 weeks after treatment initiation
R0 Resection Rate
The proportion of participants undergoing curative-intent resection who achieve microscopically margin-negative resection, with no residual tumor at the proximal, distal, or applicable circumferential resection margins.
Measured: At curative-intent surgery following completion of neoadjuvant treatment, approximately 13 to 15 weeks after treatment initiation
Event-Free Survival (EFS)
Event-free survival is defined as the time from the first dose of study treatment to the earliest occurrence of disease progression during neoadjuvant treatment, clinical deterioration preventing planned surgery, unresectable disease identified at surgery, postoperative recurrence, or death from any cause. Participants without an event will be censored at the date of their last event-free assessment.
Measured: From the first dose of study treatment through up to 5 years
Recurrence-Free Survival (RFS)
Recurrence-free survival is defined as the time from curative-intent resection to the first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first. Participants without recurrence or death will be censored at the date of their last disease assessment.
Measured: From curative-intent surgery through up to 5 years
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause. Participants who are alive or lost to follow-up will be censored at the date they were last known to be alive.
Measured: From the first dose of study treatment through up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting Liu, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727993
- Sponsor's protocol ID
- BEAT-GC-001
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing de-identified individual participant data has not yet been finalized. The decision will be made after study completion, taking into account participant consent, ethics committee approval, applicable institutional policies, data security requirements, and the scientific merit of individual data requests.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Phase Ib/II Study of Neoadjuvant Propranolol Plus SOX Chemotherapy and Toripalimab in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07727993
- Acronym / sponsor ID
- BEAT-GC-001
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma, Propranolol, SOX Chemotherapy, Toripalimab
- Keywords
- gastric or gastroesophageal junction adenocarcinoma, propranolol, OX chemotherapy, toripalimab, neoadjuvant therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Ting LiuUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jul 2026 (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-center, prospective, open-label, single-arm, phase Ib/II study evaluating the safety and efficacy of neoadjuvant propranolol combined with SOX chemotherapy and toripalimab in patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 49 participants will be enrolled. Stage 1 includes an initial safety lead-in of 12 participants, followed by efficacy evaluation using a Simon two-stage design. Participants will receive propranolol, toripalimab, oxaliplatin, and S-1 during the neoadjuvant period, followed by curative-intent surgery.
The primary efficacy endpoint is pathological complete response. Secondary endpoints include safety and tolerability, major pathological response, R0 resection rate, event-free survival, recurrence-free survival, and overall survival. Exploratory analyses will assess changes in adrenergic stress markers, heart rate variability, peripheral immune parameters, β-adrenergic receptor signaling, and the tumor immune microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol Plus SOX and Toripalimab | Experimental | Drug: propranolol, Drug: Toripalimab, Drug: Oxaliplatin, Drug: S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary participation in the study, with written informed consent, and willingness and ability to comply with the study treatment and follow-up requirements.
- Male or female participants aged 18 to 75 years.
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma.Resectable locally advanced disease as determined by imaging assessment or a multidisciplinary team according to the eighth edition of the American Joint Committee on Cancer staging system, generally defined as cT3-4a with any N category, or any T category with node-positive disease, corresponding to stage II-III disease, without distant metastasis.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Acceptable cardiopulmonary function, including all of the following:
Key exclusion criteria (17 listed)
- Distant metastatic disease confirmed by imaging or diagnostic laparoscopy, including but not limited to peritoneal, hepatic, or bone metastases, or positive peritoneal cytology.
- Previous systemic anticancer treatment for the current malignancy, including chemotherapy, immunotherapy, or targeted therapy, or previous radiotherapy. Diagnostic endoscopy and biopsy are permitted.
- Grade 2 or higher peripheral neuropathy at baseline.
- A second primary malignancy requiring systemic treatment within the previous 3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, low-risk thyroid cancer, or other malignancies considered cured.
- Inability to tolerate curative-intent surgery or study treatment, as determined by the investigator.
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 |
|---|---|---|
| propranololPropranolol will be administered orally at 10 mg twice daily beginning on Day 1 of the first neoadjuvant treatment cycle. The dose may be reduced to 5 mg twice daily, temporarily interrupted, or discontinued according to tolerability and predefined safety criteria, including heart rate, blood pressure, respiratory symptoms, and cardiac conduction abnormalities. Propranolol may be continued during postoperative treatment until completion of adjuvant therapy or the occurrence of unacceptable toxicity. | Drug | Propranolol Plus SOX and Toripalimab |
| ToripalimabToripalimab will be administered intravenously at a fixed dose of 240 mg on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. After surgery, 3 additional cycles are recommended, followed by toripalimab maintenance as clinically appropriate for a total immunotherapy duration of up to 1 year from the first dose. | Drug | Propranolol Plus SOX and Toripalimab |
| OxaliplatinOxaliplatin will be administered intravenously at 130 mg/m² on Day 1 of each 21-day cycle. Participants will receive 3 neoadjuvant cycles before surgery. Three additional postoperative cycles are recommended according to postoperative recovery, tolerability, and the investigator's assessment. Dose modification, interruption, or discontinuation will be permitted for treatment-related toxicity. | Drug | Propranolol Plus SOX and Toripalimab |
| S-1S-1 will be administered orally twice daily on Days 1-14 of each 21-day cycle, followed by a 7-day rest period. The total daily dose will be determined according to body surface area: 80 mg/day for body surface area below 1.25 m², 100 mg/day for body surface area of 1.25-1.49 m², and 120 mg/day for body surface area of 1.50 m² or greater. Participants will receive 3 neoadjuvant cycles, with 3 additional postoperative cycles recommended according to tolerability and postoperative recovery. | Drug | Propranolol Plus SOX and Toripalimab |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At curative-intent surgery following completion of 3 neoadjuvant treatment cycles, approximately 13 to 15 weeks after treatment initiation.
The proportion of participants with no residual viable tumor cells in the resected primary tumor and all dissected regional lymph nodes following neoadjuvant treatment, corresponding to Becker grade 1a. Participants who do not undergo surgery or do not have an assessable pathological result will be classified as non-pCR in the intention-to-treat analysis.
8 secondary outcomes
Dose-Limiting Toxicity (DLT) Rate During the Safety Lead-in
Time frame: From the first dose of study treatment through 30 days after surgery
Incidence of Treatment-Related Adverse Events
Time frame: From the first dose of study treatment through at least 30 days after the last dose, or until treatment-related adverse events have resolved or stabilized
Postoperative Complication Rate
Time frame: Within 30 days after surgery
Major Pathological Response (MPR) Rate
Time frame: At curative-intent surgery following completion of neoadjuvant treatment, approximately 13 to 15 weeks after treatment initiation
R0 Resection Rate
Time frame: At curative-intent surgery following completion of neoadjuvant treatment, approximately 13 to 15 weeks after treatment initiation
Event-Free Survival (EFS)
Time frame: From the first dose of study treatment through up to 5 years
Recurrence-Free Survival (RFS)
Time frame: From curative-intent surgery through up to 5 years
Overall Survival (OS)
Time frame: From the first dose of study treatment through up to 5 years
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing de-identified individual participant data has not yet been finalized. The decision will be made after study completion, taking into account participant consent, ethics committee approval, applicable institutional policies, data security requirements, and the scientific merit of individual data requests.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing propranolol, Toripalimab and Oxaliplatin in people with Gastric or Gastroesophageal Junction Adenocarcinoma and Propranolol, run by Ting Liu.
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 14 inclusion and 17 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Qing Li, PhD (+8618702848178, liqing@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At curative-intent surgery following completion of 3 neoadjuvant treatment cycles, approximately 13 to 15 weeks after treatment initiation.). 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 27 Jul 2026.