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New cocktail of drugs could shrink stomach tumors before surgery

NCT ID NCT07069712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This study tests several new drug combinations given before and after surgery for stomach or esophageal cancer. About 100 people with resectable tumors will receive these treatments to see if they are safe and can shrink or eliminate the cancer. The goal is to improve outcomes by attacking the cancer more effectively before surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD0901, Rilvegostomig, Trastuzumab Deruxtecan, Capecitabine, 5-Fluorouracil, FLOT chemotherapy
What this could lead to
If successful, this could lead to better treatment options before surgery for stomach cancer, potentially improving survival and reducing recurrence.
What could go wrong
This is an early-phase trial with only 100 participants, so results may not apply to everyone. The new drug combinations may cause side effects or not work better than current treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2029

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 years and older

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.

Inclusion Criteria: * Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease * Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and bone marrow function * Body weight \> 35 kg Exclusion Criteria: * Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer. * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment * Central nervous system (CNS) pathology * Uncontrolled infections * Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis * History of another primary malignancy * Participants with any known or suspicious distant metastasis * Uncontrolled hepatitis B and/or chronic or active hepatitis B * Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    58 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Newark, Delaware, 19713, United States

  • Research Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    RECRUITING

    Fairway, Kansas, 66205, United States

  • Research Site

    RECRUITING

    North Shores, Michigan, 49444, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10032, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Site

    SUSPENDED

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    RECRUITING

    Beijing, 100142, China

  • Research Site

    RECRUITING

    Changchun, 130021, China

  • Research Site

    RECRUITING

    Changzhi, 046000, China

  • Research Site

    RECRUITING

    Chengdu, 610041, China

  • Research Site

    RECRUITING

    Chengdu, 610042, China

  • Research Site

    NOT_YET_RECRUITING

    Fuzhou, 350014, China

  • Research Site

    RECRUITING

    Hangzhou, 310003, China

  • Research Site

    RECRUITING

    Hangzhou, 310014, China

  • Research Site

    RECRUITING

    Kunming, 650118, China

  • Research Site

    RECRUITING

    Qingdao, 266003, China

  • Research Site

    RECRUITING

    Shanghai, 200025, China

  • Research Site

    WITHDRAWN

    Shijiazhuang, 050020, China

  • Research Site

    RECRUITING

    Tbilisi, 0112, Georgia

  • Research Site

    RECRUITING

    Tbilisi, 0114, Georgia

  • Research Site

    RECRUITING

    Tbilisi, 0144, Georgia

  • Research Site

    RECRUITING

    Tbilisi, 0159, Georgia

  • Research Site

    RECRUITING

    Florence, 50134, Italy

  • Research Site

    RECRUITING

    Milan, 20133, Italy

  • Research Site

    RECRUITING

    Milan, 20141, Italy

  • Research Site

    RECRUITING

    Milan, 20162, Italy

  • Research Site

    WITHDRAWN

    Modena, 41124, Italy

  • Research Site

    RECRUITING

    Pisa, 56100, Italy

  • Research Site

    RECRUITING

    Rozzano, 20089, Italy

  • Research Site

    NOT_YET_RECRUITING

    Udine, 33100, Italy

  • Research Site

    RECRUITING

    Vicenza, 36100, Italy

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Fukuoka, 812-8582, Japan

  • Research Site

    RECRUITING

    Hidaka-shi, 350-1298, Japan

  • Research Site

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Nagoya, 464-8681, Japan

  • Research Site

    RECRUITING

    Osaka, 541-8567, Japan

  • Research Site

    WITHDRAWN

    Osaka, 558-8558, Japan

  • Research Site

    RECRUITING

    Suita-shi, 565-0871, Japan

  • Research Site

    RECRUITING

    Yokohama, 241-8515, Japan

  • Research Site

    WITHDRAWN

    Bialystok, 15-027, Poland

  • Research Site

    WITHDRAWN

    Warsaw, 02-034, Poland

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    RECRUITING

    Elche, 03203, Spain

  • Research Site

    RECRUITING

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Ourense, 32005, Spain

  • Research Site

    RECRUITING

    Oviedo, 33011, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    RECRUITING

    Valencia, 46010, Spain

  • Research Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Research Site

    RECRUITING

    Tainan, 704, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Research Site

    WITHDRAWN

    Adapazarı, 54100, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Erzurum, 25240, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Fatih-Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    WITHDRAWN

    Bristol, BS2 8ED, United Kingdom

  • Research Site

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    RECRUITING

    Headington, OX3 7LJ, United Kingdom

  • Research Site

    WITHDRAWN

    London, E1 1BB, United Kingdom

  • Research Site

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

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