unresectable metastatic colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed unresectable metastatic colorectal adenocarcinoma 2.Refractory to prior fluoropyrimidine and oxaliplatin therapy 3.No history of TAS-102, regorafenib and irinotecan therapy 4.Patient has measurable region 5.ECOG PS 0 or 1 6.Age 20<, <75 7.Patient has adequate organ function 8.Women of childbearing potential must have a negative pregnancy test 9.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Patient has serious illness or medical condition 2.Patient has had treatment with any of the following within the specified time frame prior to study drug administration a.Major surgery within prior 4 weeks b.Any anticancer drug therapy within prior 2 weeks c.Radiation within prior 2 weeks. 3.Patient has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapy 4.Pregnant or lactating female 5.Inappropriate for entry into this study in the judgment of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Time to treatment failure, Overall survival, Objective response rate, Disease control rate, Adverse event | — |
Contacts
Aichi Cancer Center Hospital