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AzTrials

Locally Advanced Hepatocellular CarcinomaPhase 2NCT05168163

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

A Phase 2 study testing Atezolizumab, Cabozantinib and Lenvatinib in people with Locally Advanced Hepatocellular Carcinoma and Metastatic Hepatocellular Carcinoma, run by Academic and Community Cancer Research United at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Cabozantinib and Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
16 sitesUnited States
Study dates
27 May 2022to 31 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent =< 28 days prior to randomization
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up
  • Age >= 18 years
  • Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria
  • Locally advanced, metastatic and/or unresectable disease that is not amendable to curative treatment
Show all 32Show fewer
  • Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease
  • NOTE: 2nd line patients only
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Child Pugh class A
  • Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) serology tests.
  • For subjects with active HBV, HBV deoxyribonucleic acid (DNA) < 500 IU/mL obtained ≤ =< 28 days prior to randomization, and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue treatment for the length of the study
  • At least one measurable untreated malignant lesion per RECIST v1.1. Subjects who previously received local therapy (e.g., ablation, percutaneous ethanol injection, trans-arterial embolization/chemo-embolization) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1
  • Consent to using archival tumor tissues, if available
  • NOTE: Non-availability of tumor tissue does not exclude the subject.
  • Willingness to provide mandatory blood specimens for correlative research
  • Willingness to provide mandatory tissue specimens for correlative research for the first 10 patients per arm (Mayo Clinic Rochester and Mayo Clinic Arizona ONLY)
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (1500/uL) without granulocyte colony-stimulating factor support (obtained =< 28 days prior to randomization)
  • Lymphocyte count >= 0.5 x 10^9/L (500/uL) (obtained =< 28 days prior to randomization)
  • Platelet count >= 75 x 10^9/L (75,000/uL) (obtained =< 28 days prior to randomization)
  • Hemoglobin >= 90 g/L (9 g/dL) (obtained =< 28 days prior to randomization)
  • Subjects may be transfused to meet this criterion
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 5 x upper limit of normal (ULN) (obtained =< 28 days prior to randomization)
  • Total bilirubin =< 3 x ULN (obtained =< 28 days prior to randomization)
  • Serum albumin >= 30 g/L (3.0 g/dL) (obtained =< 28 days prior to randomization)
  • For subjects not receiving therapeutic anticoagulation: international normalized ratio (INR) or partial thromboplastin time (aPTT) =< 1.5 × ULN (obtained =< 28 days prior to randomization)
  • Serum creatinine =< 2 x ULN or creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula) (obtained =< 28 days prior to randomization)
  • Negative pregnancy test done =< 14 days prior to randomization, for women of childbearing potential only
  • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to grade =< 1 prior to randomization, with the exception of alopecia and peripheral sensory neuropathy.
  • Subjects of childbearing potential agree to use two forms of medically approved contraception while taking the study drug and for at least 5 months after the last dose of atezolizumab or multi-kinase inhibitor. Subjects with partners of childbearing potential agree to use condoms, even after vasectomy, to avoid potential drug exposure to partner during study drug and for 5 months following the last dose of study drug
  • Ability to take oral medications

Who cannot join

  • Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma
  • Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)
  • NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed >= 6 months prior to randomization
  • Any of the following prior therapies:
  • Major surgery =< 4 weeks prior to randomization; Minor surgery =< 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines/Mediport). Subjects with clinically relevant complications from prior surgery are not eligible
  • Any anti-cancer agent =< 2 weeks prior to randomization
Show all 52Show fewer
  • Radiation therapy =< 4 weeks (1 week for palliative radiation for bone metastases and/or for pain control) or radionuclide treatment (e.g., I-131 or Y-90) =< 6 weeks prior to randomization
  • Treatment with investigational therapy =< 28 days prior to randomization
  • Known brain or leptomeningeal metastasis
  • Known co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) will be considered non-infected with HCV
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:
  • Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
  • Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the subject at high risk from treatment complication
  • Treatment with a live, attenuated vaccine =< 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or =< 5 months after the last dose of atezolizumab
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Subjects with untreated or incompletely treated esophageal/gastric varices with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to local institutional standards) without any episodes of recurrent gastrointestinal bleeding requiring transfusion or hospitalization for > 28 days prior to randomization are eligible
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) =< 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to randomization
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Note: Prior treatment with atezolizumab is permitted
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF alpha agents) =< 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study
  • Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible
  • For subjects who are to receive cabozantinib: Treatment with strong inducers and/or strong inhibitors of CYP3A4 =< 14 days prior to randomization, including rifampin (and its analogues) or St. John's wort. See https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers for lists of known strong inhibitors and strong inducers of CYP3A4
  • Active tuberculosis
  • Other uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including:
  • Symptomatic congestive heart failure, unstable angina, or serious cardiac arrythmias
  • Uncontrolled hypertensions defined as sustained blood pressure (BP) > 150 mmHg systolic BP, or > 100 mmHg diastolic BP despite optimal antihypertensive treatment
  • Stroke (including transient ischemic attack), myocardial infarction, or other ischemic event =< 3 months prior to randomization.
  • Unstable arrythmia
  • Thromboembolic event =< 3 months prior to randomization. Subjects with thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible.
  • Active bacterial infection requiring systemic treatment. Subjects on prophylactic antibiotics are eligible.
  • Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) related illness. Subjects with known HIV but without clinical evidence of an immunocompromised state and receiving anti-retroviral therapy are eligible
  • Prior allogenic stem cell or solid organ transplantation
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Subjects with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
  • Uncontrolled tumor-related pain
  • Patients requiring pain medication must be on a stable regimen at the time of randomization
  • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
  • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization
  • Other malignancy(ies) =< 5 years prior to randomization except adequately treated non-melanotic skin cancer, carcinoma-in-situ of the cervix, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of study medication
  • Uncontrolled hepatic encephalopathy occurring =< 6 weeks prior to randomization NOTE: Patients with =< grade 2 encephalopathy =< 6 weeks prior to randomization are eligible and supportive measures such as lactulose and antibiotics are allowed

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

United States16 sites, 12 recruiting

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

    Christina Velfing, 734-712-4950, christina.velfing@stjoeshealth.org

    Elie G. Dib

    Recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Cindy Rekowski, 734-232-0753, crekowsk@med.umich.edu

    Oxana V. Crysler

    Not yet recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Deeponpaul Singh, 716-845-8270, deeponpaul.singh@roswellpark.org

    Renuka V. Iyer

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Amanda Spratt, 734-232-0753, aspratt@bsd.uchicago.edu

    Chih-Yi Liao

    Not yet recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Withdrawn

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Completed

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Withdrawn

  • Froedtert and the Medical College of Wisconsin LAPS

    Milwaukee, Wisconsin, 53226

    Dawn Carini, (414) 805-0789, dcarini@mcw.edu

    Marc Casati, (414) 805-4923, mcasati@mcw.edu

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Stacey L. Zindars, 414-805-8913, szindars@mcw.edu

    Aditya Shreenivas

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Jyostna Fuloira, 504-702-4410, juotsna.fuloria@lcmchealth.org

    Jyotsna Fuloria

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Jackie Hahn-Efrati, (412) 330-6311, jacqueline.hahnefrati@ahn.org

    Dulabh K. Monga

    Recruiting

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

    Angie Dunbar, 605-755-2370, adunbar@monument.health

    Abdel-Ghani Azzouqa

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Katie L Wittenberger, Wittenberger.Kathleen@mayo.edu

    Lori Martinez, 507-293-2335, martinez.lori@mayo.edu

    Recruiting

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

    Laurie Mihalik, 480-342-3256, mihalik.laurie@mayo.edu

    Tanios S. Bekaii-Saab

    Recruiting

  • Carle Cancer Center NCI Community Oncology Research Program

    Urbana, Illinois, 61801

    Hannah Parks, 217-326-3150, Hannah.Parks@Carle.com

    Suparna Mantha

    Recruiting

  • Cleveland Clinic Weston Florida

    Weston, Florida, 33331

    Withdrawn

Other trials in United States

About this study

Official title: A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab

This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the progression-free and overall survival in subjects with advanced hepatocellular carcinoma who previously progressed on atezolizumab/bevacizumab who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone.

SECONDARY OBJECTIVES:

  1. To determine the overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 response in subjects who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone.

II. To determine the duration of response in subjects who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone.

III. To determine the safety profile of adding atezolizumab to multi-kinase inhibitor in subjects who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone.

EXPLORATORY OBJECTIVE:

  1. To explore for potential predictive biomarkers for response and resistance to anti-PD-L1 and/or multi-kinase inhibitor therapy in subject population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 and cabozantinib orally (PO) once daily (QD) or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed-up every 9 weeks for up to 2 years.

Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • CabozantinibDrug

    Given PO

  • LenvatinibDrug

    Also called E7080, ER-203492-00, Multi-Kinase Inhibitor E7080

    Given PO

Study groups in NCT05168163
Study groupRoleWhat they receive
Arm A (atezolizumab, cabozantinib or lenvatinib)ExperimentalPatients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Atezolizumab; Drug: Cabozantinib; Drug: Lenvatinib
Arm B (cabozantinib or lenvatinib)Active comparatorPatients receive cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cabozantinib; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    The final analysis for OS will be conducted when 84 OS events are observed, approximately 36 months after first subject in and will be evaluated with a one-sided p-value from stratified log-rank test.

    Measured: From randomization to death from any cause, assessed up to 3 years

  2. Progression-free survival (PFS)

    PFS analysis will be conducted when 89 PFS events are observed. The one-sided p-value from stratified log-rank test will be used for decision making.

    Measured: From randomization to first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or death, assessed up to 2 years

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Objective response is defined as either a complete response (CR) or partial response (PR) (as defined by the RECIST 1.1). ORR will be calculated by the number of subjects experience objective response divided by the number of evaluable subjects in each arm. Confidence intervals for the ORR will be calculated using a normal approximation and the corresponding 95% confidence interval will be reported.

    Measured: Up to 2 years

  2. Duration of response

    For subjects who experience a CR or PR, duration of response is defined as the time from the date of first response (CR or PR) to progression or death, whichever is earliest. Median duration for each arm and corresponding 95% confidence interval, calculated using Kaplan-Meier method and Brookmeyer-Crowley, will be reported.

    Measured: Up to 2 years

  3. Incidence of adverse events (AEs)

    Common Terminology Criteria for Adverse Events (CTCAE) AEs will be recorded for each subject. The overall adverse event rates for grade 3 or higher AEs will be reported by arm.

    Measured: Up to 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start27 May 2022
  3. Primary completion30 Jun 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168163
Sponsor's protocol ID
ACCRU-GI-2008
Other IDs
NCI-2021-12091, ACCRU-GI-2008, P30CA015083
Status last verified
Aug 2026
First submitted
8 Dec 2021
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Cabozantinib and Lenvatinib in people with Locally Advanced Hepatocellular Carcinoma and Metastatic Hepatocellular Carcinoma, run by Academic and Community Cancer Research United at 16 sites in United States.

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 32 inclusion and 52 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization to death from any cause, assessed up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168163.

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 4 Aug 2026.

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