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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Dose-limiting toxicities（DLT）
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 30 days after the last dose
Pharmacokinetics（Plasma concentration of ONO-7913）
Time frame: Through study completion, an average of 1 year.
Pharmacokinetics（Plasma concentration of ONO-4538）
Time frame: Through study completion, an average of 1 year.
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 1 year.
Overall Survival (OS)
Time frame: Through study completion, an average of 3 years.
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 1 years.
Duration of Response (DOR)
Time frame: Through study completion, an average of 1 years.
Time to Response (TTR)
Time frame: Through study completion, an average of 1 years.
Best Overall Response (BOR)
Time frame: Through study completion, an average of 1 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
...and 7 more locations
Percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 1 years.
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 1 years.
Early Tumor shrinkage（ETS）
Time frame: Up to 8 weeks
Change From Baseline in Tumour Biomarkers (CEA and CA19-9)
Time frame: Through study completion, an average of 1 year.