New hope for stomach cancer: experimental drug combo tested

NCT ID NCT06256328

Ongoing Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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