ONO-4578-08:A study to investigate the efficacy and safety of ONO-4578 in combination with nivolumab and chemotherapy compared with those of placebo in combination with nivolumab and chemotherapy in chemotherapy-naive participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

JRCT ID: jRCT2031230389

Registered date:12/10/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Unresectable Advanced or Recurrent
Gastric Cancer

• Date of first enrollment: 15/12/2023
• Target sample size: 210
• Countries of recruitment: Korea,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): ONO-4578 or placebo will be used in combination with nivolumab and chemotherapy (S-1 plus oxaliplatin combination therapy [SOX therapy] or capecitabine plus oxaliplatin combination therapy [CapeOX therapy]).

Outcome(s)

• Primary Outcome: Efficacy (PFS)
• Secondary Outcome: Efficacy(OS and others) and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
2. Patients have not been treated with systemic chemotherapy as first-line therapy
3. Patients who can provide tumor tissue samples

Exclude criteria

1. Patients unable to take oral medicines
2. Patients with HER2-positive
3. Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
4. 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
5. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
6. Patients with headache and/or nausea associated with brain metastasis

Related Information

• Primary Sponsor: Hirashima Yoshinori