ONO-4578-03:ONO-4578 Phase 1 Study

JRCT ID: jRCT2051200096

Registered date:15/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Resectable rectal cancer
• Date of first enrollment: 20/01/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): ONO-4578 and combinations of ONO-4578 and ONO-4538 as neoadjuvant therapy

Outcome(s)

• Primary Outcome: Safety, tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Rectal adenocarcinoma
2. Patients with ECOG performance status 0 or 1

Exclude criteria

1. Patients with severe complication
2. Patients with multiple primary cancers

Related Information

• Primary Sponsor: Hirashima Yoshinori