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Desmoplastic Small Round Cell TumorPhase 2ISG-TULIPSNCT07328425

Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS

A Phase 2 study testing Lurbinectedin and Irinotecan in people with Desmoplastic Small Round Cell Tumor, run by Italian Sarcoma Group at 11 sites in 2 countries.

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

Patients participating in this study have DSRCT that has spread locally or to other parts of the body and can no longer be surgically removed without causing significant harm. Treatment will continue until the tumor progresses further, severe side effects occur, or either patient or investigator decision. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Desmoplastic Small Round Cell Tumor
What is being tested?
Lurbinectedin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesin 2 countries
Study dates
21 Nov 2025to 1 Oct 2030
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological centrally confirmed diagnosis of DSRCT with the documented presence of EWSR1-WT1 translocation.
  • Age ≥ 15 years.
  • Locally advanced (i.e. radical surgical resection of local disease unfeasible or surgery declined by the patient or surgery deemed to become less demolitive and / or easier after cytoreduction) and/or metastatic disease.
  • Measurable disease by RECIST v1.1.
  • Clinical or objective disease progression after the last administration of the last standard therapy, or have stopped standard therapy due to intolerability within 6 months from enrollment.
  • At least one prior chemotherapy based on anthracycline (considering chemotherapy administered for primary tumour) and no more than 3 prior chemotherapy lines.
Show all 22Show fewer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
  • Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the trial), defined as the following:
  • platelet count ≥ 100 × 109/L, hemoglobin ≥ 9.0 g/dL, white blood cells ≥ 3.0 × 109/L and absolute neutrophil count (ANC) ≥ 2.0 × 109/L,
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × the upper limit of normal (ULN), even in the presence of liver metastases,
  • total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN,
  • International Normalized Ratio (INR) < 1.5 (except if patient is on oral anticoagulation therapy),
  • calculated creatinine clearance (CrCL) ≥ 30 mL/minute (using Cockcroft-Gault formula),
  • creatine phosphokinase (CPK) ≤ 2.5 × ULN,
  • albumin ≥ 3.0 g/dL.
  • Cardiac ejection fraction ≥50% as measured by echocardiogram.
  • Recovery to grade ≤ 1 or to baseline from any adverse event (AE) derived from previous treatment (excluding alopecia and/or cutaneous toxicity and/or fatigue grade ≤ 2).
  • No history of arterial and/or venous thromboembolic event within the previous 12 months.
  • Females of childbearing potential must have a negative pregnancy test (preferable by serum or, if serum test unavailable, urine beta-HCG) within 7 days before treatment start.
  • Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
  • Male and female patients of reproductive potential must agree to employ a highly effective method of birth control (Acceptable methods of contraception are described in Appendix 5) throughout the study and thereafter, at the end of study treatment, and for at least 7 months from the patient's last lurbinectedin administration in female patients of childbearing potential and for at least 4 months in men in fertile age after the last lurbinectedin administration.
  • The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.

Who cannot join

  • Prior treatment with lurbinectedin or trabectedin, Ecubectedin (PM 14) or PM54.
  • Known hypersensitivity to irinotecan or lurbinectedin or any of their components of the drugs products (excipients).
  • Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse.
  • History or presence of unstable angina, myocardial infarction, or clinically significant valvular heart disease within 12 months of the study.
  • Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 12 months of study).
  • Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment within 12 months of study.
Show all 24Show fewer
  • Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart).
  • Severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Known active brain metastasis.
  • Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis).
  • Diagnosis of human deficiency virus (HIV), hepatitis C virus (HCV) infection or active hepatitis B (to be excluded during the screening period).
  • Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or sub-occlusion or paralysis.
  • Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
  • Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
  • Known active COVID-19 disease (this includes positive test for SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs or nasal swabs by PCR).
  • Prior bone marrow and/or stem cell transplantation, and allogenic transplant.
  • Last dose of systemic cytotoxic therapy or investigational therapy within 21 days from enrollment.
  • Prior treatment with any form of radiation therapy within 14 days from enrollment.
  • Major surgery within 3 weeks prior to study entry and minor surgery within 1 week prior to study entry.
  • Use of strong inducers of CYP3A activity within two weeks prior to the first infusion of lurbinectedin (Appendix 6).
  • Expected limitation of the patient's ability to comply with the treatment or follow-up protocol.
  • Subjects who have current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver metastasis or stable chronic liver disease per Investigator assessment).
  • Subjects who have known Gilbert's syndrome.
  • Patient has received a live or liver attenuated vaccines within 30 days before the first dose of study intervention. Killed vaccines are allowed.

Trial locations and contacts

11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gianluca Ignazzi contact

+393335359192

gianluca.ignazzi@italiansarcomagroup.org

Viviana Appolloni contact

+393756073789

viviana.appolloni@italiansarcomagroup.org

11 sites in 2 countries

Spain6 sites, 6 recruiting

  • Vall d'Hebron University Hospital

    Barcelona, 08035

    Claudia Valverde, MD, cvalverde@vhio.net

    Claudia Valverde

    Not yet recruiting

  • Hospital Clinico Universitario San Carlos

    Madrid, 28040

    Gloria Marquina Ospina, MD, gloria.marquina@salud.madrid.org

    Gloria Marquina

    Not yet recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Nadia Hindi, MD, nhindi@atbsarc.org

    Nadia Hindi

    Recruiting

  • Virgen of Arrixaca University Clinical Hospital

    Murcia, 30120

    Jose Luis Alonso, MD

    Jose Luis Alonso

    Not yet recruiting

  • Hospital Univ. Virgen del Rocío

    Seville, 41013

    Irene Carrasco Garcìa, MD

    Irene Carrasco Garcìa

    Not yet recruiting

  • Hospital Univ. Miguel Servet

    Zaragoza, 50009

    Javier Martinez, MD

    Javier Martinez

    Not yet recruiting

Other trials in Spain

Italy5 sites, 5 recruiting

  • Fondazione del Piemonte per l'Oncologia IRCCS

    Candiolo, Torino, 10060

    Sandra Aliberti, MD, sandra.aliberti@ircc.it

    Sandra Aliberti

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Silvia Stacchiotti, MD, silvia.stacchiotti@istitutotumori.mi.it

    Silvia Stacchiotti, MD

    Recruiting

  • IOV Istituto Oncologico Veneto IRCCS

    Padova, 35128

    Antonella Brunello, MD, antonella.brunello@iov.veneto.it

    Antonella Brunello

    Recruiting

  • Nuovo Ospedale "S.Stefano"

    Prato, 59100

    Giacomo Giulio Baldi, MD, giacomo.baldi@istitutotumori.mi.it

    Giacomo Giulio Baldi

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, 00128

    Alessandro Mazzocca, MD, a.mazzocca@policlinicocampus.it

    Alessandro Mazzocca

    Recruiting

Other trials in Italy

About this study

Official title: Phase II Study of Lurbinectedin and Irinotecan in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT)

Patients participating in this study have DSRCT that has spread locally or to other parts of the body and can no longer be surgically removed without causing significant harm.

Treatment will continue until the tumor progresses further, severe side effects occur, or either patient or investigator decision.

In addition, patients may participate in an optional biological study. The study will analyze the tumor's genes and the molecules related to them. By studying genes and their products, the investigators can better understand the behavior of the tumor and how the body responds to therapies.

Read the detailed description

This is an Italian and Spanish multicentric, prospective, phase II single-arm, open-label, investigator-initiated clinical study that will be conducted within the Italian Sarcoma Group (ISG) and the Spanish Sarcoma Groups (GEIS), aiming at exploring the activity of lurbinectedinin combination with irinotecan, until progression or unacceptable toxicity, in a population of =/>15 years old patients with histologically and molecularly confirmed (EWSR1-WT1 translocation positive), advanced (locally advanced or metastatic) DSRCT, from 2nd to 4th line, following progression to anthracycline-based chemotherapy.

The primary end-point of the study will be the overall response rate (ORR) by RECIST v1.1 in the study population. Secondary end-points will be PFS, DoR, OS, safety and changes in QoL.

Patients will be evaluated for the primary end-point if have completed at least one cycle of lurbinectedin and irinotecan and have at least one post-baseline radiologic disease assessment. Patients with documented early progression disease (PD) or who die due to PD before the first scheduled tumor assessment will also be included in the analysis.

Patients will be followed for follow up visits every 6 months for 2 years.

Being tested
Lurbinectedin, Irinotecan
Medical subject headings
Desmoplastic Small Round Cell Tumor

What participants receive

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

  • LurbinectedinDrug

    Lurbinectedin and Irinotecan

  • IrinotecanDrug

    Lurbinectedin and Irinotecan

Study groups in NCT07328425
Study groupRoleWhat they receive
Lurbinectedine and IrinotecanExperimentallurbinectedin in combination with intravenous irinotecan administered until progression or unacceptable toxicity, in a population of =/>15 years old patients with histologically and molecularly confirmed (EWSR1-WT1 translocation positive), advanced (locally advanced or metastatic) DSRCT, from 2nd to 4th line, following progression to anthracycline-based chemotherapy.
Receives: Drug: Lurbinectedin; Drug: Irinotecan

What is being measured

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

  1. Overall tumour Response Rate (ORR), according to RECIST v 1.1

    Overall tumour Response Rate (ORR), according to RECIST v 1.1

    Measured: Week 6, week 12, week 18, week 30, week 42, week 54, week 66, week 78, week 90, week 102 and until progression

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall Survival (OS)

    Measured: From date of study therapy start until the date of death from any cause, assessed up to 60 months

  2. Progression Free Survival (PFS)

    Progression Free Survival (PFS)

    Measured: From date of study therapy start until first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  3. Duration of Response (DoR)

    Duration of Response (DoR)

    Measured: From date of study therapy start until first documented assessment without progression or date of death from any cause, whichever came first, assessed up to 60 months

  4. Adverse events and Serious adverse event (according to CTC-AE v.5)

    Adverse events and Serious adverse event (according to CTC-AE v.5)

    Measured: After initiation of study treatments(s), all adverse events will be reported until 30 days after the final dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first.

  5. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a validated 30-item questionnaire assessing health-related quality of life in cancer patients. Scores are linearly transformed to a 0 to 100 scale.

    For the Global Health Status/Quality of Life and functional scales (physical, role, emotional, cognitive, and social functioning), higher scores indicate better quality of life or functioning.

    For the symptom scales and single-item symptom measures, higher scores indicate greater symptom severity (worse outcome).

    Measured: Screening, cycle1 day1 (each cycle is 21 days), cycle2 day1, End Of Treatment visit (performed 30 days after the last study drug administration), at follow-up visits performed at months 6, 12, 18 and 24 after the last study drug administration

  6. Brief Inventory Pain questionnaire

    Brief Inventory Pain questionnaire

    Measured: Screening, cycle1 day1 (each cycle is 21 days), cycle2 day1, End Of Treatment visit (performed 30 days after the last study drug administration), at follow-up visits performed at months 6, 12, 18 and 24 after the last study drug administration

Timeline

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

  1. First posted9 Jan 2026
  2. Study start21 Nov 2025
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion1 Oct 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328425
Sponsor's protocol ID
ISG-TULIPS
Other IDs
2024-519261-21-00
Acronym
ISG-TULIPS
Status last verified
Nov 2026
First submitted
17 Nov 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jayakrishnan T, Moll R, Sandhu A, Sanguino A, Kaur G, Mao S. Desmoplastic Small Round-cell Tumor: Retrospective Review of Institutional Data and Literature Review. Anticancer Res. 2021 Aug;41(8):3859-3866. doi: 10.21873/anticanres.15179.

    PubMed 34281846

  • Hayes-Jordan AA, Coakley BA, Green HL, Xiao L, Fournier KF, Herzog CE, Ludwig JA, McAleer MF, Anderson PM, Huh WW. Desmoplastic Small Round Cell Tumor Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Results of a Phase 2 Trial. Ann Surg Oncol. 2018 Apr;25(4):872-877. doi: 10.1245/s10434-018-6333-9. Epub 2018 Jan 30.

    PubMed 29383611

  • Rosoff PM, Bayliff S. Successful clinical response to irinotecan in desmoplastic round blue cell tumor. Med Pediatr Oncol. 1999 Nov;33(5):500-3. doi: 10.1002/(sici)1096-911x(199911)33:53.0.co;2-x. No abstract available.

    PubMed 10531577

  • Honore C, Amroun K, Vilcot L, Mir O, Domont J, Terrier P, Le Cesne A, Le Pechoux C, Bonvalot S. Abdominal desmoplastic small round cell tumor: multimodal treatment combining chemotherapy, surgery, and radiotherapy is the best option. Ann Surg Oncol. 2015 Apr;22(4):1073-9. doi: 10.1245/s10434-014-4123-6. Epub 2014 Oct 10.

    PubMed 25300608

  • Stacchiotti S, Frezza AM, Blay JY, Baldini EH, Bonvalot S, Bovee JVMG, Callegaro D, Casali PG, Chiang RC, Demetri GD, Demicco EG, Desai J, Eriksson M, Gelderblom H, George S, Gounder MM, Gronchi A, Gupta A, Haas RL, Hayes-Jardon A, Hohenberger P, Jones KB, Jones RL, Kasper B, Kawai A, Kirsch DG, Kleinerman ES, Le Cesne A, Lim J, Chirlaque Lopez MD, Maestro R, Marcos-Gragera R, Martin Broto J, Matsuda T, Mir O, Patel SR, Raut CP, Razak ARA, Reed DR, Rutkowski P, Sanfilippo RG, Sbaraglia M, Schaefer IM, Strauss DC, Sundby Hall K, Tap WD, Thomas DM, van der Graaf WTA, van Houdt WJ, Visser O, von Mehren M, Wagner AJ, Wilky BA, Won YJ, Fletcher CDM, Dei Tos AP, Trama A. Ultra-rare sarcomas: A consensus paper from the Connective Tissue Oncology Society community of experts on the incidence threshold and the list of entities. Cancer. 2021 Aug 15;127(16):2934-2942. doi: 10.1002/cncr.33618. Epub 2021 Apr 28.

    PubMed 33910263

  • Saab R, Khoury JD, Krasin M, Davidoff AM, Navid F. Desmoplastic small round cell tumor in childhood: the St. Jude Children's Research Hospital experience. Pediatr Blood Cancer. 2007 Sep;49(3):274-9. doi: 10.1002/pbc.20893.

    PubMed 16685737

  • Liu KX, Collins NB, Greenzang KA, Furutani E, Campbell K, Groves A, Mullen EA, Shusterman S, Spidle J, Marcus KJ, Weil BR, Weldon CB, Frazier AL, Janeway KA, O'Neill AF, Mack JW, DuBois SG, Shulman DS. The use of interval-compressed chemotherapy with the addition of vincristine, irinotecan, and temozolomide for pediatric patients with newly diagnosed desmoplastic small round cell tumor. Pediatr Blood Cancer. 2020 Oct;67(10):e28559. doi: 10.1002/pbc.28559. Epub 2020 Jul 19.

    PubMed 32686305

  • Verret B, Honore C, Dumont S, Terrier P, Adam J, Cavalcanti A, Sourrouille I, Klausner G, Ahlenc-Gelas M, Kiavue N, Domitrescu G, El Amarti L, Mir O, Le Cesne A. Trabectedin in advanced desmoplastic round cell tumors: a retrospective single-center series. Anticancer Drugs. 2017 Jan;28(1):116-119. doi: 10.1097/CAD.0000000000000435.

    PubMed 27782906

  • Giani C, Radaelli S, Miceli R, Gandola L, Sangalli C, Frezza AM, Provenzano S, Pasquali S, Bertulli R, Fiore M, Callegaro D, Casanova M, Chiaravalli S, Collini P, Dagrada GP, Morosi C, Zaffaroni N, Casali PG, Ferrari A, Gronchi A, Stacchiotti S. Long-term survivors with desmoplastic small round cell tumor (DSRCT): Results from a retrospective single-institution case series analysis. Cancer Med. 2023 May;12(9):10694-10703. doi: 10.1002/cam4.5829. Epub 2023 Mar 23.

    PubMed 36951537

  • Brunetti AE, Delcuratolo S, Lorusso V, Palermo L, Di Giorgio A, Pisconti S, Silvestris N. Third-line trabectedin for a metastatic desmoplastic small round cell tumour treated with multimodal therapy. Anticancer Res. 2014 Jul;34(7):3683-8.

    PubMed 24982387

  • Leal JF, Martinez-Diez M, Garcia-Hernandez V, Moneo V, Domingo A, Bueren-Calabuig JA, Negri A, Gago F, Guillen-Navarro MJ, Aviles P, Cuevas C, Garcia-Fernandez LF, Galmarini CM. PM01183, a new DNA minor groove covalent binder with potent in vitro and in vivo anti-tumour activity. Br J Pharmacol. 2010 Nov;161(5):1099-110. doi: 10.1111/j.1476-5381.2010.00945.x.

    PubMed 20977459

  • Lettieri CK, Garcia-Filion P, Hingorani P. Incidence and outcomes of desmoplastic small round cell tumor: results from the surveillance, epidemiology, and end results database. J Cancer Epidemiol. 2014;2014:680126. doi: 10.1155/2014/680126. Epub 2014 Nov 5.

    PubMed 25431592

  • Zuco V, Pasquali S, Tortoreto M, Percio S, Doldi V, Barisella M, Collini P, Dagrada GP, Brich S, Gasparini P, Fiore M, Casanova M, Frezza AM, Gronchi A, Stacchiotti S, Ferrari A, Zaffaroni N. Effectiveness of irinotecan plus trabectedin on a desmoplastic small round cell tumor patient-derived xenograft. Dis Model Mech. 2023 Jun 1;16(6):dmm049649. doi: 10.1242/dmm.049649. Epub 2023 Jun 14.

    PubMed 37158111

  • Scheer M, Vokuhl C, Blank B, Hallmen E, von Kalle T, Munter M, Wessalowski R, Hartwig M, Sparber-Sauer M, Schlegel PG, Kramm CM, Kontny U, Spriewald B, Kegel T, Bauer S, Kazanowska B, Niggli F, Ladenstein R, Ljungman G, Jahnukainen K, Fuchs J, Bielack SS, Klingebiel T, Koscielniak E; Cooperative Weichteilsarkom Studiengruppe [CWS]. Desmoplastic small round cell tumors: Multimodality treatment and new risk factors. Cancer Med. 2019 Feb;8(2):527-542. doi: 10.1002/cam4.1940. Epub 2019 Jan 16.

    PubMed 30652419

  • Stiles ZE, Dickson PV, Glazer ES, Murphy AJ, Davidoff AM, Behrman SW, Bishop MW, Martin MG, Deneve JL. Desmoplastic small round cell tumor: A nationwide study of a rare sarcoma. J Surg Oncol. 2018 Jun;117(8):1759-1767. doi: 10.1002/jso.25071. Epub 2018 Jun 7.

    PubMed 29878371

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lurbinectedin and Irinotecan in people with Desmoplastic Small Round Cell Tumor, run by Italian Sarcoma Group at 11 sites in 2 countries.

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 22 inclusion and 24 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain, Italy. 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?

Contact Gianluca Ignazzi (+393335359192, gianluca.ignazzi@italiansarcomagroup.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall tumour Response Rate (ORR), according to RECIST v 1.1 (time frame: Week 6, week 12, week 18, week 30, week 42, week 54, week 66, week 78, week 90, week 102 and until progression). 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 NCT07328425, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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