Gastrointestinal NeoplasmsPhase 3NCT04592913
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
A Phase 3 study testing Durvalumab and FLOT chemotherapy in people with Gastrointestinal Neoplasms and Esophagogastric Junction, run by AstraZeneca at 156 sites in 20 countries.
Trial summary
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN). Read more about this study
- Who is it for?
- Ages 18 to 200 years
- Conditions the study is for
- Gastrointestinal Neoplasms, Esophagogastric Junction
- What is being tested?
- Durvalumab and FLOT chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 957 participants
- Where
- 156 sitesin 20 countries
- Study dates
- 17 Nov 2020to 27 Sep 2027
- Phase
- Phase 3
- 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 200 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- Patients must undergo radical surgery.
- No prior anti-cancer therapy for the current malignancy.
- World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- Adequate organ and marrow function.
- Availability of tumor sample prior to study entry.
- Must have a life expectancy of at least 24 weeks.
Who cannot join
- Patients with peritoneal dissemination or distant metastasis.
- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Contra-indication to any of the study drugs.
- History of allogeneic organ transplantation.
Trial locations and contacts
156 sites in 20 countries.
156 sites in 20 countries
Japan19 sites
Research Site
Chūōku, 104-0045
Research Site
Hidaka-shi, 350-1298
Research Site
Hirakata-shi, 573-1191
Research Site
Hiroshima, 730-8518
Research Site
Kashiwa, 277-8577
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kochi, 781-8555
Research Site
Kurume-shi, 830-0011
Research Site
Nagoya, 464-8681
Research Site
Niigata, 951-8566
Research Site
Ogaki-shi, 503-8502
Research Site
Osaka, 534-0021
Research Site
Osaka, 541-8567
Research Site
Suita-shi, 565-0871
Research Site
Sunto-gun, 411-8777
Research Site
Tokyo, 135-8550
Research Site
Toyoake-shi, 470-1192
Research Site
Wakayama, 641-8510
Research Site
Yokohama, 241-8515
United States16 sites
Research Site
Boston, Massachusetts, 02215
Research Site
Dallas, Texas, 75390
Research Site
Duarte, California, 91010
Research Site
Fort Wayne, Indiana, 46804
Research Site
Lancaster, Texas, 75216
Research Site
Los Angeles, California, 90027
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40217
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10065
Research Site
Rochester, New York, 14642
Research Site
Seattle, Washington, 98109
Research Site
St. Petersburg, Florida, 33705
Research Site
Sylmar, California, 91342
Research Site
Tallahassee, Florida, 32308
Research Site
West Palm Beach, Florida, 33401
France12 sites
Research Site
Avignon, 84918
Research Site
Besançon, 25030
Research Site
Brest, 29609
Research Site
Dijon, 21000
Research Site
Lyon, 69373
Research Site
Montpellier, 34298
Research Site
Nantes, 44093
Research Site
Nice, 06100
Research Site
Paris, 75012
Research Site
Paris, 75475
Research Site
Paris, 75900
Research Site
Rennes, 35033
Germany12 sites
Research Site
Berlin, 13353
Research Site
Dresden, 01307
Research Site
Frankfurt, 60488
Research Site
Hamburg, 20246
Research Site
Hamburg, 20249
Research Site
Heidelberg, 69120
Research Site
Heilbronn, 74078
Research Site
Jena, 7743
Research Site
Mainz Am Rhein, 55131
Research Site
München, 81675
Research Site
Schweinfurt, 97421
Research Site
Tübingen, 72016
Spain10 sites
Research Site
Barcelona, 08025
Research Site
Barcelona, 08035
Research Site
Barcelona, 08908
Research Site
Madrid, 28007
Research Site
Madrid, 28034
Research Site
Málaga, 29009
Research Site
Ourense, 32005
Research Site
Santander, 39008
Research Site
Seville, 41013
Research Site
Valencia, 46010
Poland8 sites
Research Site
Bialystok, 15-027
Research Site
Gdansk, 80-952
Research Site
Krakow, 30-688
Research Site
Lodz, 93-513
Research Site
Poznan, 60-569
Research Site
Poznan, 61-866
Research Site
Warsaw, 02-034
Research Site
Warsaw, 04-141
United Kingdom8 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Dundee, DD1 9SY
Research Site
Glasgow, G12 0YN
Research Site
Leicester, LE2 7LZ
Research Site
London, EC1A 7BE
Research Site
Manchester, M20 4BX
Research Site
Oxford, OX3 7LE
Research Site
Surrey, SM2 5PT
Brazil7 sites
Research Site
Barretos, 14784-400
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90035-903
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 20231-050
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01246-000
Russia7 sites
Research Site
Kaluga, 248007
Research Site
Moscow, 111123
Research Site
Moscow, 115478
Research Site
Moscow, 125284
Research Site
Novosibirsk, 630108
Research Site
Obninsk, 249036
Research Site
Saint Petersburg, 197089
Argentina6 sites
Research Site
Buenos Aires, C1431FWO
Research Site
Ciudad Autonoma Buenos Aires, 1093
Research Site
Ciudad de Buenos Aires, 1280
Research Site
Ciudad de Buenos Aires, C1426ANZ
Research Site
Rosario, 3101
Research Site
Rosario, S2000DEJ
Canada6 sites
Research Site
Edmonton, Alberta, t6G1Z2
Research Site
Montreal, Quebec, H2X 0A9
Research Site
Montreal, H3T 1E2
Research Site
North York, Ontario, M2K 1E1
Research Site
Oshawa, Ontario, L1G 2B9,
Research Site
Toronto, Ontario, M5G 2M9
Chile6 sites
Research Site
La Serena, 1720430
Research Site
Santiago, 7500653
Research Site
Santiago, 7500921
Research Site
Talca, 3461341
Research Site
Temuco, 4800827
Research Site
Temuco, 4810218
South Korea6 sites
Research Site
Hwasun-gun, 58128
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Taiwan6 sites
Research Site
Kaohsiung City, 807
Research Site
Taichung, 40443
Research Site
Tainan, 70403
Research Site
Taipei, 10048
Research Site
Taipei, 112
Research Site
Taoyuan City, 333
Turkey (Türkiye)6 sites
Research Site
Adana, 01120
Research Site
Ankara, 06340
Research Site
Erzurum, 25240
Research Site
Istanbul, 34098
Research Site
Istanbul, 34457
Research Site
Samsun, 55139
Belgium5 sites
Research Site
Charleroi, 6060
Research Site
Edegem, 2650
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Roeselare, 8800
Hungary5 sites
Research Site
Budapest, 1122
Research Site
Győr, 9024
Research Site
Kecskemét, 6000
Research Site
Szekszárd, 7100
Research Site
Szolnok, 5004
Peru5 sites
Research Site
Bellavista, CALLAO 2
Research Site
Lima, LIMA 29
Research Site
Lima, Lima 32
Research Site
Lima, LIMA 34
Research Site
San Isidro, 27
Denmark3 sites
Research Site
Aalborg, 9000
Research Site
København Ø, 2100
Research Site
Odense, 5000
Netherlands3 sites
Research Site
Amsterdam, 1066 CX
Research Site
Eindhoven, 5623EJ
Research Site
Rotterdam, 3015GD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Read the detailed description
This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.
- Being tested
- Durvalumab, FLOT chemotherapy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Human monoclonal antibody
FLOT chemotherapyDrug
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Placebo comparator | placebo product and FLOT chemotherapy Receives: Drug: FLOT chemotherapy |
| Arm A | Experimental | Durvalumab and FLOT chemotherapy Receives: Drug: Durvalumab; Drug: FLOT chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Measured: Up to 5 years
Secondary outcomes (2)
To compare Arm A relative to Arm B on overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
Measured: Up to 5 years
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Measured: 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 posted19 Oct 2020
- Study start17 Nov 2020
- Primary completion20 Dec 2024
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 957 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592913
- Sponsor's protocol ID
- D910GC00001
- Other IDs
- 2019-001555-40, 2019
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Bragagnoli AC, Garbaos G, Liberman M, Miron MLL, Smyth EC, Cheng LY, Robbins SH, Valeri N, Xynos I, Tabernero J; MATTERHORN investigators. Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet. 2026 Sep 9:S0140-6736(26)01254-7. doi: 10.1016/S0140-6736(26)01254-7. Online ahead of print.
PubMed 42716074Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701. Epub 2025 Jun 1.
PubMed 40454643Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
PubMed 35623069Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
PubMed 35535555Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.
PubMed 35179774
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
- ClinicalTrials.gov ID
- NCT04592913
- Acronym / sponsor ID
- D910GC00001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 957 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 19 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 Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Detailed description
This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Arm B | Placebo comparator | Drug: FLOT chemotherapyplacebo product and FLOT chemotherapy |
| Arm A | Experimental | Drug: Durvalumab, Drug: FLOT chemotherapyDurvalumab and FLOT chemotherapy |
Who may qualify
- Ages
- 18 to 200 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- Patients must undergo radical surgery.
- No prior anti-cancer therapy for the current malignancy.
- World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- Adequate organ and marrow function.
Key exclusion criteria (5 listed)
- Patients with peritoneal dissemination or distant metastasis.
- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Contra-indication to any of the study drugs.
- History of allogeneic organ transplantation.
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 |
|---|---|---|
| DurvalumabHuman monoclonal antibody | Drug | Arm A |
| FLOT chemotherapyA combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel | Drug | Arm A, Arm B |
Primary outcome
Event-free survival (EFS)
Time frame: Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.
2 secondary outcomes
To compare Arm A relative to Arm B on overall survival (OS)
Time frame: Up to 5 years
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
Time frame: 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 24 Dec 2025.
- Derived from this study: PubMed 42716074Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Bragagnoli AC, Garbaos G, Liberman M, Miron MLL, Smyth EC, Cheng LY, Robbins SH, Valeri N, Xynos I, Tabernero J; MATTERHORN investigators. Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet. 2026 Sep 9:S0140-6736(26)01254-7. doi: 10.1016/S0140-6736(26)01254-7. Online ahead of print.
- Derived from this study: PubMed 40454643Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701. Epub 2025 Jun 1.
- Derived from this study: PubMed 35623069Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
- Derived from this study: PubMed 35535555Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
- Derived from this study: PubMed 35179774Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
156 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab and FLOT chemotherapy in people with Gastrointestinal Neoplasms and Esophagogastric Junction, run by AstraZeneca at 156 sites in 20 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 156 sites in Japan, United States, France, Germany, Spain and 15 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Event-free survival (EFS) (time frame: Up to 5 years). 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 NCT04592913, which also lists 5 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 24 Dec 2025.