Gastric Cancer Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
| Status | Recruiting |
| Enrollment | 210 |
| Est. completion date | December 31, 2027 |
| Est. primary completion date | November 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hyogo Cancer Center | Akashi-shi | Hyogo |
| Japan | JOHAS Kansai Rosai Hospital | Amagasaki-shi | Hyougo |
| Japan | Osaka International Cancer Institute | Chuo-ku | Osaka |
| Japan | Kyushu University Hospital | Fukuoka-shi | Fukuoka |
| Japan | NHO Kyushu Cancer Center | Fukuoka-shi | Fukuoka |
| Japan | Kansai Medical University Hospital | Hirakata-shi | Osaka |
| Japan | Hiroshima City Hiroshima Citizens Hospital | Hiroshima-shi | Hiroshima |
| Japan | Saitama Cancer Center | Ina-machi, Kitaadati-gun | Saitama |
| Japan | Ishikawa Prefectural Central Hospital | Kanazawa-shi | Ishikawa |
| Japan | Ibaraki Prefectural Central Hospital | Kasama-shi | Ibaraki |
| Japan | National Cancer Center Hospital East | Kashiwa-shi | Chiba |
| Japan | Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe-shi | Hyogo |
| Japan | Cancer Institute Hospital of JFCR | Koto-ku | Tokyo |
| Japan | Kurashiki Central Hospital | Kurashiki-shi | Okayama |
| Japan | Matsuyama Red Cross Hospital | Matsuyama-shi | Ehime |
| Japan | NHO Shikoku Cancer Center | Matsuyama-shi | Ehime |
| Japan | Kagawa University Hospital | Miki-cho, Kita-gun | Kagawa |
| Japan | IMSUT Hospital, The Institute of Medical Science, The University of Tokyo | Minato-Ku | Tokyo |
| Japan | Shizuoka Cancer Center | Nagaizumi-cho, Sunto-gun | Shizuoka |
| Japan | Aichi Cancer Center Hospital | Nagoya-shi | Aichi |
| Japan | Osaka Metropolitan University Hospital | Osaka | |
| Japan | Osaki Citizen Hospital | Osaki-shi | Miyagi |
| Japan | Gunma Prefectural Cancer Center | Ota-shi | Gunma |
| Japan | Kitasato University Hospital | Sagamihara-shi | Kanagawa |
| Japan | Kindai University Hospital | Sayama-shi | Osaka |
| Japan | Tohoku University Hospital | Sendai-shi | Miyagi |
| Japan | Keio University Hospital | Shinjuku-ku | Tokyo |
| Japan | Osaka General Medical Center | Sumiyoshi-ku | Osaka |
| Japan | Osaka Medical and Pharmaceutical University Hospital | Takatsuki-shi | Osaka |
| Japan | Iwate Medical University Hospital | Yahaba-cho, Shiwa-gun | Iwate |
| Japan | JCHO Kyushu Hospital | Yahatanishi-ku, Kitakyusyu-shi | Fukuoka |
| Japan | Kanagawa Cancer Center | Yokohama-shi | Kanagawa |
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | Gangwon-do |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do |
| Korea, Republic of | Keimyung University Dongsan Hospital | Daegu | |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
| Korea, Republic of | Yeungnam University Hospital | Daegu | |
| Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun-gun | Jeollanam-do |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Inha University Hospital | Incheon | |
| Korea, Republic of | Jeonbuk national university hospital | Jeonju-si | Jeollabuk-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
| Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | |
| Korea, Republic of | Ajou University Hospital | Suwon | Gyeonggi-do |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan-si | Gyeongsangnam-do |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Chi Mei Hospital, Liouying | Tainan | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharmaceutical Co. Ltd |
Japan, Korea, Republic of, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) (site investigator assessment) | up to 2years | ||
| Secondary | Overall survival (OS) | up to 2years | ||
| Secondary | Objective response rate (ORR) (site investigator assessment) | up to 2years | ||
| Secondary | Best overall response (BOR) (site investigator assessment) | up to 2years | ||
| Secondary | Duration of response (DOR) (site investigator assessment) | up to 2years | ||
| Secondary | Disease control rate (DCR) (site investigator assessment) | up to 2years | ||
| Secondary | Time to response (TTR) (site investigator assessment) | up to 2years | ||
| Secondary | Maximum percent change in the sum diameters of the target lesions (site investigator assessment) | up to 2years | ||
| Secondary | Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) | up to 2years | ||
| Secondary | Adverse event (AE) | Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 | Up to 30 days after the last dose |
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