Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for stomach cancer: experimental drug combo tested

NCT ID NCT06256328

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding an experimental drug (ONO-4578) to standard immunotherapy (nivolumab) and chemotherapy helps people with advanced HER2-negative stomach cancer. About 226 participants who have not had prior chemotherapy will receive either the experimental combo or a placebo plus standard treatment. The study aims to see if the new combination can slow cancer growth and improve survival.

What this could mean

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

Active substance
ONO-4578 (an experimental drug) combined with nivolumab (Opdivo) and chemotherapy (oxaliplatin, capecitabine, or S-1)
What this could lead to
If successful, this could offer a new treatment option for people with advanced gastric cancer, potentially slowing disease progression.
What could go wrong
This is an early phase 2 trial with 226 participants, so results are not yet proven. The experimental drug may not improve outcomes and could cause additional side effects.

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

226 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jul 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 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: * Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma * Patients have not been treated with systemic chemotherapy as first-line therapy * Patients who can provide tumor tissue samples Exclusion Criteria: * Patients unable to take oral medicines * Patients with HER2-positive * Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine * Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment * Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis * Patients with headache and/or nausea associated with brain metastasis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gastric cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm

As listed by the trial registrant

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

Gastric cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, Japan

  • Ajou University Hospital

    Suwon, Gyeonggi-do, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, South Korea

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, Japan

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, South Korea

  • Dong-A University Hospital

    Busan, South Korea

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, Japan

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, South Korea

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, Japan

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, Japan

  • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

    Minato-Ku, Tokyo, Japan

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki, Japan

  • Inha University Hospital

    Incheon, South Korea

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, Japan

  • Iwate Medical University Hospital

    Yahaba-cho, Shiwa-gun, Iwate, Japan

  • JCHO Kyushu Hospital

    Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, Japan

  • JOHAS Kansai Rosai Hospital

    Amagasaki-shi, Hyōgo, Japan

  • Jeonbuk national university hospital

    Jeonju, Jeollabuk-do, South Korea

  • Kagawa University Hospital

    Miki-cho, Kita-gun, Kagawa-ken, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Keio University Hospital

    Shinjuku-ku, Tokyo, Japan

  • Kindai University Hospital

    Sayama-shi, Osaka, Japan

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, Japan

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo, Japan

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kosin University Gospel Hospital

    Busan, Gangwon-do, South Korea

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken, Japan

  • Kyung Hee University Hospital

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • Kyushu University Hospital

    Fukuoka, Fukuoka, Japan

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, Japan

  • NHO Kyushu Cancer Center

    Fukuoka, Fukuoka, Japan

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime, Japan

  • National Cancer Center

    Goyang-si, Gyeonggi-do, South Korea

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, Japan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Osaka General Medical Center

    Sumiyoshi-ku, Osaka, Japan

  • Osaka International Cancer Institute

    Chuo-ku, Osaka, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, Japan

  • Osaki Citizen Hospital

    Osaki-shi, Miyagi, Japan

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, South Korea

  • Saitama Cancer Center

    Ina-machi, Kitaadati-gun, Saitama, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shizuoka Cancer Center

    Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, South Korea

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • Ulsan University Hospital

    Ulsan, South Korea

  • Yeungnam University Hospital

    Daegu, South Korea

More trials for these conditions

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