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Cure My Disease

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Promising combo aims to keep stomach cancer at bay after surgery

NCT ID NCT04592913

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug durvalumab to standard chemotherapy (FLOT) before and after surgery helps people with resectable stomach or gastroesophageal junction cancer live longer without the cancer returning. About 957 participants receive either durvalumab or a placebo alongside chemo, followed by surgery and then more durvalumab or placebo. The main goal is to see if the drug combo delays cancer progression or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

957 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 200 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

digestive system neoplasm gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophagogastric junction Gastrointestinal neoplasms

Contacts and locations

Locations

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Los Angeles, California, 90027, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Sylmar, California, 91342, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Tallahassee, Florida, 32308, United States

  • Research Site

    West Palm Beach, Florida, 33401, United States

  • Research Site

    Fort Wayne, Indiana, 46804, United States

  • Research Site

    Louisville, Kentucky, 40217, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Dallas, Texas, 75390, United States

  • Research Site

    Lancaster, Texas, 75216, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Buenos Aires, C1431FWO, Argentina

  • Research Site

    Ciudad Autonoma Buenos Aires, 1093, Argentina

  • Research Site

    Ciudad de Buenos Aires, 1280, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1426ANZ, Argentina

  • Research Site

    Rosario, 3101, Argentina

  • Research Site

    Rosario, S2000DEJ, Argentina

  • Research Site

    Charleroi, 6060, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Porto Alegre, 90035-903, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    Edmonton, Alberta, t6G1Z2, Canada

  • Research Site

    North York, Ontario, M2K 1E1, Canada

  • Research Site

    Oshawa, Ontario, L1G 2B9,, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H2X 0A9, Canada

  • Research Site

    Montreal, H3T 1E2, Canada

  • Research Site

    La Serena, 1720430, Chile

  • Research Site

    Santiago, 7500653, Chile

  • Research Site

    Santiago, 7500921, Chile

  • Research Site

    Talca, 3461341, Chile

  • Research Site

    Temuco, 4800827, Chile

  • Research Site

    Temuco, 4810218, Chile

  • Research Site

    Aalborg, 9000, Denmark

  • Research Site

    København Ø, 2100, Denmark

  • Research Site

    Odense, 5000, Denmark

  • Research Site

    Avignon, 84918, France

  • Research Site

    Besançon, 25030, France

  • Research Site

    Brest, 29609, France

  • Research Site

    Dijon, 21000, France

  • Research Site

    Lyon, 69373, France

  • Research Site

    Montpellier, 34298, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Nice, 06100, France

  • Research Site

    Paris, 75012, France

  • Research Site

    Paris, 75475, France

  • Research Site

    Paris, 75900, France

  • Research Site

    Rennes, 35033, France

  • Research Site

    Berlin, 13353, Germany

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Frankfurt, 60488, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hamburg, 20249, Germany

  • Research Site

    Heidelberg, 69120, Germany

  • Research Site

    Heilbronn, 74078, Germany

  • Research Site

    Jena, 7743, Germany

  • Research Site

    Mainz Am Rhein, 55131, Germany

  • Research Site

    München, 81675, Germany

  • Research Site

    Schweinfurt, 97421, Germany

  • Research Site

    Tübingen, 72016, Germany

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Kecskemét, 6000, Hungary

  • Research Site

    Szekszárd, 7100, Hungary

  • Research Site

    Szolnok, 5004, Hungary

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Hidaka-shi, 350-1298, Japan

  • Research Site

    Hirakata-shi, 573-1191, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    Kochi, 781-8555, Japan

  • Research Site

    Kurume-shi, 830-0011, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Ogaki-shi, 503-8502, Japan

  • Research Site

    Osaka, 534-0021, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Tokyo, 135-8550, Japan

  • Research Site

    Toyoake-shi, 470-1192, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Amsterdam, 1066 CX, Netherlands

  • Research Site

    Eindhoven, 5623EJ, Netherlands

  • Research Site

    Rotterdam, 3015GD, Netherlands

  • Research Site

    Bellavista, CALLAO 2, Peru

  • Research Site

    Lima, LIMA 29, Peru

  • Research Site

    Lima, Lima 32, Peru

  • Research Site

    Lima, LIMA 34, Peru

  • Research Site

    San Isidro, 27, Peru

  • Research Site

    Bialystok, 15-027, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Krakow, 30-688, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Poznan, 60-569, Poland

  • Research Site

    Poznan, 61-866, Poland

  • Research Site

    Warsaw, 02-034, Poland

  • Research Site

    Warsaw, 04-141, Poland

  • Research Site

    Kaluga, 248007, Russia

  • Research Site

    Moscow, 111123, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 125284, Russia

  • Research Site

    Novosibirsk, 630108, Russia

  • Research Site

    Obninsk, 249036, Russia

  • Research Site

    Saint Petersburg, 197089, Russia

  • Research Site

    Hwasun-gun, 58128, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Barcelona, 08025, Spain

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 08908, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Málaga, 29009, Spain

  • Research Site

    Ourense, 32005, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46010, Spain

  • Research Site

    Kaohsiung City, 807, Taiwan

  • Research Site

    Taichung, 40443, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 10048, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taoyuan City, 333, Taiwan

  • Research Site

    Adana, 01120, Turkey (Türkiye)

  • Research Site

    Ankara, 06340, Turkey (Türkiye)

  • Research Site

    Erzurum, 25240, Turkey (Türkiye)

  • Research Site

    Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    Istanbul, 34457, Turkey (Türkiye)

  • Research Site

    Samsun, 55139, Turkey (Türkiye)

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    Glasgow, G12 0YN, United Kingdom

  • Research Site

    Leicester, LE2 7LZ, United Kingdom

  • Research Site

    London, EC1A 7BE, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Oxford, OX3 7LE, United Kingdom

  • Research Site

    Surrey, SM2 5PT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.