The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
- Conditions
- Unresectable Colorectal Cancer
- Interventions
- Registration Number
- NCT06540261
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Unresectable advanced or recurrent colorectal cancer
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
- Patients with severe complication
- Patients with multiple primary cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONO-7913＋ONO-4538＋FOLFOX＋Bev ONO-4538 - ONO-7913＋ONO-4538＋FOLFOX＋Bev Levofolinate - ONO-7913＋ONO-4538＋FOLFOX＋Cet ONO-7913 - ONO-7913＋ONO-4538＋FOLFOX＋Cet ONO-4538 - ONO-7913＋ONO-4538＋FOLFOX＋Cet Levofolinate - ONO-7913＋ONO-4538＋FOLFOX＋Bev ONO-7913 - ONO-7913＋ONO-4538＋FOLFOX＋Bev Fluorouracil - ONO-7913＋ONO-4538＋FOLFOX＋Bev Oxaliplatin - ONO-7913＋ONO-4538＋FOLFOX＋Bev Bevacizumab - ONO-7913＋ONO-4538＋FOLFOX＋Cet Fluorouracil - ONO-7913＋ONO-4538＋FOLFOX＋Cet Oxaliplatin - ONO-7913＋ONO-4538＋FOLFOX＋Cet Cetuximab -
- Primary Outcome Measures
Name Time Method Dose-limiting toxicities（DLT） 28 days Adverse event (AE) Up to 30 days after the last dose
- Secondary Outcome Measures
Name Time Method Pharmacokinetics（Plasma concentration of ONO-4538） Through study completion, an average of 1 year. Early Tumor shrinkage（ETS） Up to 8 weeks Overall Survival (OS) Through study completion, an average of 3 years. Duration of Response (DOR) Through study completion, an average of 1 years. Percent change in the sum diameters of the target lesions Through study completion, an average of 1 years. Pharmacokinetics（Plasma concentration of ONO-7913） Through study completion, an average of 1 year. Disease Control Rate (DCR) Through study completion, an average of 1 year. Time to Response (TTR) Through study completion, an average of 1 years. Objective Response Rate (ORR) Through study completion, an average of 1 year. Progression-Free Survival (PFS) Through study completion, an average of 1 years. Best Overall Response (BOR) Through study completion, an average of 1 years. Maximum percent change in the sum diameters of the target lesions Through study completion, an average of 1 years. Change From Baseline in Tumour Biomarkers (CEA and CA19-9) Through study completion, an average of 1 year.
Trial Locations
- Locations (17)
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Okayama, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
St. Marianna University Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Saitama Cancer Center
🇯🇵Ina, Saitama, Japan
National Cancer Center Hospital
🇯🇵Chuo Ku, Toyko, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan